Label: THERAFLU COLD AND FLU- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder
- NDC Code(s): 0067-8135-10
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated December 27, 2022
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- TheraFlu® Cold and Flu Forest Berries
One packet contains:
Active ingredients: paracetamol 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg.
- Pharmacotherapeutic group:
Increased sensitivity to individual ingredients of the preparation, simultaneous use of tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic blockers; portal hypertension; alcoholism; diabetes mellitus, pregnancy, breast-feeding, children under 12 years of age.
With caution: in marked coronary artery atherosclerosis, in arterial hypertension, narrow-angle glaucoma, severe liver or kidney diseases, prostatic hyperplasia, blood diseases, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, and Rotor syndromes), hyperthyroidism, pheochromocytoma, bronchial asthma.
Dosage and administration:
Oral. The content of a packet is dissolved in 1 glass of boiling hot water. Consumed in hot form. Sugar can be added to taste. A repeated dose may be taken every 4 hours (no more than 3 doses in 24 hours).
TheraFlu® can be used at any time of day, but taking the preparation before going to sleep, for the night, has the best effect. If there is no relief of symptoms within 3 days after the preparation is first taken, a physician must be consulted
possible allergic reactions (skin rash, pruritus, hives, angioedema), hyperexcitability, sleep disorder, reduction in the speed of psychomotor reactions, drowsiness, dizziness, nausea, vomiting, stomach pain, palpitations, blood pressure increase, dry mouth, accommodative palsy, increase in intraocular pressure, urinary retention. During prolonged use in high doses - hepatotoxic action, changes in blood count; nephrotoxicity.
Nausea, vomiting, epigastric pain, hepatotoxic and nephrotoxic action, in severe cases - hepatic insufficiency, hepatic necrosis, increase in "liver" transaminase activity, increase in prothrombin time, encephalopathy, and comatose state.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy. Administration of methionine 8-9 hours after the overdosage and N-acetylcysteine - after 12 hours. Medical attention should be sought.
Interaction with other drugs:
Intensifies the effect of MAO inhibitors, sedative preparations, ethanol. The risk of the hepatotoxic action of paracetamol increases during concurrent use of barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, and other hepatic microsomal enzyme inducers. Antidepressants, antiparkinsonian agents, antipsychotic agents, and phenothiazine derivatives - increase the risk of developing urinary retention, dry mouth, and constipation. Glucocorticosteroids increase the risk of developing elevated intraocular pressure.
To avoid toxic liver damage, the preparation should not be combined with the use of alcoholic beverages. Care should be taken when the preparation is used by individuals over 70 years of age with cardiovascular disease because of the possible vasoconstricting action of phenylephrine.
If regardless of the use of the preparation, the illness is accompanied by continuing fever or repeated temperature elevations, a physician must be consulted.
Do not exceed the recommended dose.
Do not use the preparation from damaged packets.
- Storage conditions:
- Shelf life:
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
THERAFLU COLD AND FLU
acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8135 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8135-10 10 in 1 CARTON; Type 0: Not a Combination Product 11/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 11/30/2010 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)