THERAFLU COLD AND FLU- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder

TheraFlu Cold and Flu by

Drug Labeling and Warnings

TheraFlu Cold and Flu by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TheraFlu Cold and Flu

Pharmaceutical form:Powder for oral solution (berry flavor).

Active Ingrédient

paracetamol 325.0 mg

pheniramine maleate 20.0 mg

phenylephrine hydrochloride 10.0 mg.

Purpose

• Antipyretic
• Analgesic
• Vasoconstrictive
• Decongestant
• Antiallergic

Indications:

Symptomatic therapy of infectious and inflammatory disorders: acute respiratory viral infections (ARVI) including influenza and common cold associated with: high temperature, chill, headache, sore throat, rhinitis, nasal congestion, sneezing, muscle pain.

Dosage and administration:

For oral administration. Dissolve one sachet in a glass of hot, but not boiling, water. Take hot.

Take one sachet every 4 – 6 hours as required but not more than 4 doses within 24 hours. The product should not be administered for more than 5 days.

Excipients: see patient information leaflet

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.

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:

At temperature not higher than 25°C.

Keep out of reach of children.

OTC medicine

Marketing authorisation No. ЛС-001960

Principal Display Panel

NDC: 0067-0924-01

THERAFLU

COLD & FLU

contains paracetamol 325 mg

• FEVER MUSCLE PAIN
• HEADACHE RUNNYNOSE
• SORE THROAT NASAL CONGESTION
• CHILLS SNEEZING

Berry flavour

10 SACHETS

INGREDIENTS AND APPEARANCE

THERAFLU COLD AND FLU 
acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-0924
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)