TheraFlu Cold and Flu

Manufacturer
Haleon US Holdings LLC
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:11:55

Label at a glance#

ProductTheraFlu Cold and Flu
Active ingredientACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

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

Storage and handling

At temperature not higher than 25°C.

Label contents#

Full prescribing information#

TheraFlu Cold and Flu

SPL UNCLASSIFIED SECTION

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

Active Ingrédient

OTC - ACTIVE INGREDIENT SECTION

paracetamol 325.0 mg

pheniramine maleate 20.0 mg

phenylephrine hydrochloride 10.0 mg.

Purpose

OTC - PURPOSE SECTION

  • Antipyretic
  • Analgesic
  • Vasoconstrictive
  • Decongestant
  • Antiallergic

Indications:

INDICATIONS & USAGE SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

CONTRAINDICATIONS SECTION

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:

INACTIVE INGREDIENT SECTION

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:

STORAGE AND HANDLING SECTION

At temperature not higher than 25°C.

Principal Display Panel

PACKAGE LABEL.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

Theraflu Cold and Flu Berry
Theraflu Cold and Flu Berry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionPSN4
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSCD4
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Granule for Oral SolutionSY4
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Packet for Oral SolutionSY4
1796460APAP 325 MG / Pheniramine Maleate 20 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0924-01TheraFlu Cold and Flu10 in 1 CARTONPOWDER104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0924THERAFLU COLD AND FLU (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) POWDER [HALEON US HOLDINGS LLC]41 package rows20240503_7fd78fc6-1f80-4866-bb8b-6dbf8af80482.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-09240067-0924-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
17790e66-de43-5cc4-e063-6394a90a62a77fd78fc6-1f80-4866-bb8b-6dbf8af804822024-05-02Exact identifier
spl id: 17790e66-de43-5cc4-e063-6394a90a62a7
spl set id: 7fd78fc6-1f80-4866-bb8b-6dbf8af80482

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.