THERAFLU COLD AND FLU- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder 
Haleon US Holdings LLC

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Drug Facts

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

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

Berry flavour

10 SACHETS

Theraflu Cold and Flu Berry
THERAFLU COLD AND FLU 
acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0924
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-0924-0110 in 1 CARTON; Type 0: Not a Combination Product03/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/01/2022
Labeler - Haleon US Holdings LLC (079944263)

Revised: 5/2024
Document Id: 17790e66-de43-5cc4-e063-6394a90a62a7
Set id: 7fd78fc6-1f80-4866-bb8b-6dbf8af80482
Version: 4
Effective Time: 20240502
 
Haleon US Holdings LLC