Paracetamol + Pheniramine + Ascorbic acid (Powder) Instructions for Use

Instructions
Dosage forms

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Pheniramine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Remedy for the relief of symptoms of acute respiratory infections and the “common cold”

Pharmacological Action

A combined medicinal product.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic, and weak anti-inflammatory effects. The mechanism of action is associated with the inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

Pheniramine is an antiallergic agent, a histamine H₁-receptor blocker. It relieves allergic symptoms, has a moderate sedative effect, and also exhibits m-anticholinergic activity.

Ascorbic acid participates in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; it increases the body’s resistance to infections, reduces vascular permeability, and reduces the need for vitamins B₁, B₂, A, E, folic acid, and pantothenic acid. It improves the tolerability of paracetamol and prolongs its action (associated with the prolongation of T_1/2).

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in plasma is reached within 10-60 minutes after oral administration. It is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. Binding to plasma proteins is insignificant at therapeutic concentrations but increases with higher concentrations. It undergoes primary metabolism in the liver. It is excreted mainly in the urine as glucuronides and sulfates. T_1/2 ranges from 1 to 3 hours.

C_max of pheniramine in plasma is reached in approximately 1-2.5 hours. T_1/2 of pheniramine is 16-19 hours. 70-83% of the dose is excreted from the body in the urine as metabolites or unchanged.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 25%. It is excreted in the urine as metabolites. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.

Indications

Acute respiratory viral infections (symptomatic therapy); allergic rhinitis; rhinopharyngitis; pain syndrome (mild to moderate): arthralgia, myalgia, neuralgia, migraine, toothache and headache, dysmenorrhea; pain from injuries, burns.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
G43	Migraine
J00	Acute nasopharyngitis (common cold)
J06.9	Acute upper respiratory infection, unspecified
J10	Influenza due to identified seasonal influenza virus
J30.1	Allergic rhinitis due to pollen
J30.3	Other allergic rhinitis (perennial allergic rhinitis)
K08.8	Other specified disorders of teeth and supporting structures (including toothache)
M25.5	Pain in joint
M79.1	Myalgia
M79.2	Neuralgia and neuritis, unspecified
N94.4	Primary dysmenorrhea
N94.5	Secondary dysmenorrhea
R50	Fever of unknown origin
R51	Headache
R52.0	Acute pain
R52.2	Other chronic pain
T14.3	Dislocation, sprain and strain of joint and ligament of unspecified body region
T14.9	Injury, unspecified
T30	Burns and corrosions of unspecified body region

ICD-11 code	Indication
1E30	Influenza due to identified seasonal influenza virus
8A80.Z	Migraine, unspecified
8A8Z	Headache disorders, unspecified
8E4A.1	Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
CA00	Acute nasopharyngitis
CA07.0	Acute upper respiratory tract infection of unspecified site
CA08.00	Allergic rhinitis due to pollen
CA08.03	Other allergic rhinitis
DA0A.Z	Diseases of teeth and supporting structures, unspecified
FB56	Specified soft tissue diseases, not elsewhere classified
FB56.2	Myalgia
GA34.3	Dysmenorrhea
LA30.5Z	Anomalies of tooth resorption or loss, unspecified
ME82	Pain in joint
MG26	Fever of other or unknown origin
MG30.Z	Chronic pain syndrome, unspecified
MG31.Z	Acute pain, unspecified
ND56.3	Dislocation, sprain or strain of unspecified body region
ND56.Z	Unspecified injury of unspecified part of trunk, limb or body region
NE11	Burn of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For oral administration only. Dissolve the contents of one sachet in a glass of hot water; stir until completely dissolved and allow to cool slightly before consumption.

Adhere strictly to a minimum 4-hour interval between doses. Do not exceed four doses within a 24-hour period.

For adults and adolescents aged 15 years and older, administer one sachet per single dose. The maximum daily dose is four sachets.

In patients with chronic renal failure (creatinine clearance 10 ml/min), extend the interval between single doses to 8 hours.

The duration of self-treatment without medical consultation should not exceed 3 days for fever or 5 days for pain. Discontinue use and consult a physician if symptoms persist.

Avoid concurrent use with other products containing paracetamol or other analgesic/antipyretic agents to prevent overdose.

Do not use for more than the recommended duration or at higher than the recommended doses, as this increases the risk of hepatotoxicity.

Adverse Reactions

From the digestive system: nausea, pain in the epigastric region; rarely – dry mouth; with long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired liver function increases.

From the hematopoietic system rarely – anemia, thrombocytopenia, methemoglobinemia.

From the urinary system rarely – urinary retention; with long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired renal function increases.

Allergic reactions skin rash, itching, urticaria, angioedema.

Other rarely – accommodation paresis, drowsiness.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); renal failure; portal hypertension; chronic alcoholism; children under 15 years of age (for dosage forms intended for adults); first and third trimesters of pregnancy; lactation period (breastfeeding); hypersensitivity to the components of the combination.

With caution

Hepatic failure, angle-closure glaucoma, prostatic hyperplasia, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, in elderly patients.

Use in Pregnancy and Lactation

Contraindications: first and third trimesters of pregnancy; lactation period (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated for use in liver dysfunction.

Use in Renal Impairment

With caution in renal failure.

In chronic renal failure (creatinine clearance 10 ml/min), the interval between doses is 8 hours.

Pediatric Use

Contraindication – children under 15 years of age (for dosage forms intended for adults).

Special Precautions

If hyperthermia persists for more than 3 days and pain syndrome for more than 5 days, a doctor’s consultation is required.

It distorts the indicators of laboratory tests in the quantitative determination of glucose and uric acid in plasma.

During treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

During treatment, it is necessary to refrain from consuming ethanol (development of a hepatotoxic effect is possible).

Effect on ability to drive vehicles and operate machinery

During treatment, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Ethanol enhances the sedative effect of antihistamine drugs.

Antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives) increase the risk of side effects (urinary retention, dry mouth, constipation).

Glucocorticosteroids increase the risk of glaucoma.

Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication with small overdoses.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic action.

Paracetamol reduces the effectiveness of uricosuric drugs.

With simultaneous use of oral contraceptives, the concentration of ascorbic acid in the blood plasma decreases. An increase in the concentration of ethinylestradiol in the blood plasma is possible with its simultaneous use as part of oral contraceptives.

With simultaneous use with iron preparations, Ascorbic acid, due to its reducing properties, converts ferric iron to ferrous iron, which improves its absorption.

With simultaneous use with warfarin, a decrease in the effects of warfarin is possible.

With simultaneous use, Ascorbic acid increases the excretion of iron in patients receiving deferoxamine.

With simultaneous use with tetracycline, the excretion of ascorbic acid in the urine increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Paracetamol Extra [Aliym, JSC (Russia)]
Powder for oral solution (orange) 500 mg+150 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Paracetamol Extra

Powder for oral solution (orange) 500 mg+150 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral solution granulated, orange in color, with a characteristic faint orange odor. An aqueous solution of the contents of one sachet in 100 ml of water at a temperature of 40-45°C (104-113°F) is a slightly cloudy orange solution with a characteristic faint orange odor.

	1 sachet
Paracetamol	500 mg
Ascorbic acid	150 mg

Excipients: citric acid, dextrin, orange flavor, sucrose, aspartame, sunset yellow dye.

5 g – heat-sealed sachets (5) – cardboard packs.
5 g – heat-sealed sachets (10) – cardboard packs.
5 g – heat-sealed sachets (20) – cardboard packs.
5 g – heat-sealed sachets (30) – cardboard packs.
5 g – heat-sealed sachets (40) – cardboard packs.
5 g – heat-sealed sachets (50) – cardboard packs.

Paracetamol Extra [Aliym, JSC (Russia)]
Powder for oral solution (cherry) 500 mg+150 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Paracetamol Extra

Powder for oral solution (cherry) 500 mg+150 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral solution granulated, crimson in color, with a characteristic faint cherry odor. An aqueous solution of the contents of one sachet in 100 ml of water at a temperature of 40-45°C (104-113°F) is a slightly cloudy crimson solution with a characteristic faint cherry odor.

	1 sachet
Paracetamol	500 mg
Ascorbic acid	150 mg

Excipients: citric acid, cherry flavor, dextrin, sucrose, aspartame, azorubine dye.

Paracetamol Extra [Aliym, JSC (Russia)]
Powder for oral solution (caramel) 500 mg+150 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Paracetamol Extra

Powder for oral solution (caramel) 500 mg+150 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral solution granulated, yellow in color, with a characteristic faint caramel odor. An aqueous solution of the contents of one sachet in 100 ml of water at a temperature of 40-45°C (104-113°F) is a slightly cloudy yellow solution with a characteristic faint caramel odor.

	1 sachet
Paracetamol	500 mg
Ascorbic acid	150 mg

Excipients: citric acid, caramel flavor, dextrin, sucrose, aspartame, quinoline yellow dye.

Paracetamol + Pheniramine + Ascorbic acid [Atoll LLC (Russia)]
Powder for preparation of oral solution (with lemon and honey flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
Powder for preparation of oral solution (with lemon flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
Powder for preparation of oral solution (with black currant flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
Powder for preparation of oral solution (with raspberry flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
Powder for preparation of oral solution (with chamomile flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Paracetamol + Pheniramine + Ascorbic acid	Powder for preparation of oral solution (with lemon and honey flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
		Powder for preparation of oral solution (with lemon flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
		Powder for preparation of oral solution (with black currant flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
		Powder for preparation of oral solution (with raspberry flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.
		Powder for preparation of oral solution (with chamomile flavor) 500 mg+25 mg+200 mg: pack 4.95 g 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 24 or 30 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral solution (with lemon and honey flavor) in the form of a mixture of powder and granules, white or white with a yellowish tint, with a characteristic odor; the presence of inclusions from pale yellow to light brown is allowed.

	1 sachet
Paracetamol	500 mg
Pheniramine maleate	25 mg
Ascorbic acid	200 mg

Excipients: mannitol – 3515 mg, magnesium citrate – 400 mg, citric acid monohydrate – 50 mg, aspartame – 50 mg, povidone K25 – 10 mg, lemon flavor – 150 mg, honey flavor – 50 mg.

4.95 g – heat-sealed sachets (1) – cardboard packs.
4.95 g – heat-sealed sachets (2) – cardboard packs.
4.95 g – heat-sealed sachets (3) – cardboard packs.
4.95 g – heat-sealed sachets (4) – cardboard packs.
4.95 g – heat-sealed sachets (5) – cardboard packs.
4.95 g – heat-sealed sachets (6) – cardboard packs.
4.95 g – heat-sealed sachets (7) – cardboard packs.
4.95 g – heat-sealed sachets (8) – cardboard packs.
4.95 g – heat-sealed sachets (9) – cardboard packs.
4.95 g – heat-sealed sachets (10) – cardboard packs.
4.95 g – heat-sealed sachets (12) – cardboard packs.
4.95 g – heat-sealed sachets (15) – cardboard packs.
4.95 g – heat-sealed sachets (16) – cardboard packs.
4.95 g – heat-sealed sachets (20) – cardboard packs.
4.95 g – heat-sealed sachets (24) – cardboard packs.
4.95 g – heat-sealed sachets (30) – cardboard packs.

Powder for oral solution (lemon flavored) in the form of a mixture of powder and granules white or white with a yellowish tint, with a characteristic odor; the presence of inclusions from pale yellow to light brown is allowed.

	1 sachet
Paracetamol	500 mg
Pheniramine maleate	25 mg
Ascorbic acid	200 mg

Excipients: mannitol – 3515 mg, magnesium citrate – 400 mg, citric acid monohydrate – 50 mg, aspartame – 50 mg, povidone K25 – 10 mg, lemon flavor – 200 mg.

4.95 g – thermowelded sachets (1) – cardboard packs.
4.95 g – thermowelded sachets (2) – cardboard packs.
4.95 g – thermowelded sachets (3) – cardboard packs.
4.95 g – thermowelded sachets (4) – cardboard packs.
4.95 g – thermowelded sachets (5) – cardboard packs.
4.95 g – thermowelded sachets (6) – cardboard packs.
4.95 g – thermowelded sachets (7) – cardboard packs.
4.95 g – thermowelded sachets (8) – cardboard packs.
4.95 g – thermowelded sachets (9) – cardboard packs.
4.95 g – thermowelded sachets (10) – cardboard packs.
4.95 g – thermowelded sachets (12) – cardboard packs.
4.95 g – thermowelded sachets (15) – cardboard packs.
4.95 g – thermowelded sachets (16) – cardboard packs.
4.95 g – thermowelded sachets (20) – cardboard packs.
4.95 g – thermowelded sachets (24) – cardboard packs.
4.95 g – thermowelded sachets (30) – cardboard packs.

Powder for oral solution (black currant flavored) in the form of a mixture of powder and granules white or white with a yellowish tint, with a characteristic odor; the presence of inclusions from pale yellow to light brown is allowed.

	1 sachet
Paracetamol	500 mg
Pheniramine maleate	25 mg
Ascorbic acid	200 mg

Excipients: mannitol – 3665 mg, magnesium citrate – 400 mg, citric acid monohydrate – 50 mg, aspartame – 50 mg, povidone K25 – 10 mg, black currant flavor – 50 mg.

Powder for oral solution (raspberry flavored) in the form of a mixture of powder and granules white or white with a yellowish tint, with a characteristic odor; the presence of inclusions from pale yellow to light brown is allowed.

	1 sachet
Paracetamol	500 mg
Pheniramine maleate	25 mg
Ascorbic acid	200 mg

Excipients: mannitol – 3665 mg, magnesium citrate – 400 mg, citric acid monohydrate – 50 mg, aspartame – 50 mg, povidone K25 – 10 mg, raspberry flavor – 50 mg.

Powder for oral solution (chamomile flavored) in the form of a mixture of powder and granules from white to light brown, with a characteristic odor; brown inclusions are present.

	1 sachet
Paracetamol	500 mg
Pheniramine maleate	25 mg
Ascorbic acid	200 mg

Excipients: mannitol – 3665 mg, magnesium citrate – 400 mg, citric acid monohydrate – 50 mg, aspartame – 50 mg, povidone K25 – 10 mg, chamomile flower extract – 50 mg.

Paracetamol + Phenylephrine + Ascorbic acid [Dr. Reddy's Laboratories Ltd. (India)]
Powder for oral solution (honey-lemon): 5.5 g sachets 6 or 10 pcs.
Powder for oral solution (lemon): 5.5 g sachets 6 or 10 pcs.

Marketing Authorization Holder

Dr. Reddy’s Laboratories Ltd. (India)

Dosage Forms

	Paracetamol + Phenylephrine + Ascorbic acid	Powder for oral solution (honey-lemon): 5.5 g sachets 6 or 10 pcs.
		Powder for oral solution (lemon): 5.5 g sachets 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution[honey-lemon] from white to light yellow, with single brown and black inclusions, with a characteristic smell of lemon and honey.

	1 sachet
Paracetamol	750 mg
Phenylephrine Hydrochloride	10 mg
Ascorbic acid	60 mg

Excipients: sucrose, citric acid, maltodextrin, sucralose, calcium phosphate, sodium citrate dihydrate, talc, magnesium stearate, lemon flavor (SC581048), quinoline yellow dye (E104), combined honey flavor (SC128206), caramel color.

5.5 g – sachets (6) – cardboard packs.
5.5 g – sachets (10) – cardboard packs.

Powder for oral solution[lemon] from white to light yellow, with a characteristic smell of lemon.

	1 sachet
Paracetamol	750 mg
Phenylephrine Hydrochloride	10 mg
Ascorbic acid	60 mg

Excipients: sucrose, citric acid, maltodextrin, sucralose, calcium phosphate, sodium citrate dihydrate, talc, magnesium stearate, lemon flavor (SC581048), quinoline yellow dye (E104).

5.5 g – sachets (6) – cardboard packs.
5.5 g – sachets (10) – cardboard packs.

Paracetamol Extra for children [Aliym, JSC (Russia)]
Powder for oral solution (orange) 120 mg+10 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Paracetamol Extra for children

Powder for oral solution (orange) 120 mg+10 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution granulated, orange in color, with a characteristic faint orange odor. An aqueous solution of the contents of one sachet in 100 ml of water at a temperature of 40-45°C (104-113°F) is a slightly cloudy orange solution with a characteristic orange odor.

	1 sachet
Paracetamol	120 mg
Ascorbic acid	10 mg

Excipients: citric acid, dextrin, orange flavor, sucrose, aspartame, sunset yellow dye.

1.5 g – thermowelded sachets (5) – cardboard packs.
1.5 g – thermowelded sachets (10) – cardboard packs.
1.5 g – thermowelded sachets (20) – cardboard packs.
1.5 g – thermowelded sachets (30) – cardboard packs.
1.5 g – thermowelded sachets (40) – cardboard packs.
1.5 g – thermowelded sachets (50) – cardboard packs.

Paracetamol Extra for children [Aliym, JSC (Russia)]
Powder for oral solution (cherry) 120 mg+10 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Paracetamol Extra for children

Powder for oral solution (cherry) 120 mg+10 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution granulated, crimson in color, with a characteristic faint cherry odor. An aqueous solution of the contents of one sachet in 100 ml of water at a temperature of 40-45°C (104-113°F) is a slightly cloudy crimson solution with a characteristic cherry odor.

	1 sachet
Paracetamol	120 mg
Ascorbic acid	10 mg

Excipients: citric acid, dextrin, cherry flavor, sucrose, aspartame, azorubine dye.

Paracetamol Extra for children [Aliym, JSC (Russia)]
Powder for oral solution (caramel) 120 mg+10 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Paracetamol Extra for children

Powder for oral solution (caramel) 120 mg+10 mg: sachets 5, 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution granulated, yellow in color, with a characteristic faint caramel odor. An aqueous solution of the contents of one sachet in 100 ml of water at a temperature of 40-45°C (104-113°F) is a slightly cloudy yellow solution with a characteristic caramel odor.

	1 sachet
Paracetamol	120 mg
Ascorbic acid	10 mg

Excipients: citric acid, dextrin, caramel flavor, sucrose, aspartame, quinoline yellow dye.

Medixlife (Author)

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