Label: THERAFLU COLD AND FLU- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder
- NDC Code(s): 0067-0924-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated May 2, 2024
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- TheraFlu Cold and Flu
- Active Ingrédient
- Purpose
- Indications:
- Dosage and administration:
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Contraindications:
Hypersensitivity to individual product ingredients, co-administration of tricyclic antidepressants, beta-adrenergic blockers or other sympathomimetic products, hyperthyroidism, pheochromocytoma, angle-closure glaucoma, alcoholism, pregnancy, breastfeeding, pediatric use under 12 years of age. For a complete list of contraindications, see patient information leaflet.
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Excipients:
sucrose, acesulfame potassium, Allura Red AC Е129 (FD&C red No.40), Brilliant Blue Е133 (FD&C No.1), maltodextrin, silicon dioxide, natural raspberry flavor WONF Durarome (860385 TD0994), natural cranberry Durarome flavor (861149 TD2590, citric acid anhydrous, sodium citrate dihydrate, calcium phosphate tribasic, magnesium stearate.
- Storage conditions:
- Keep out of reach of children.
- OTC medicine
- Marketing authorisation No. ЛС-001960
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
THERAFLU COLD AND FLU
acetaminophen, pheniramine maleate, phenylephrine hydrochloride powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-0924 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 SUCROSE (UNII: C151H8M554) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) MAGNESIUM STEARATE (UNII: 70097M6I30) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-0924-01 10 in 1 CARTON; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 03/01/2022 Labeler - Haleon US Holdings LLC (079944263)