Drug Facts

Set ID
ff48b55a-0d32-47d6-941d-d99c7cf52f94
Manufacturer
Haleon US Holdings LLC
Effective date
2024-02-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:08:37

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each 30 mL)

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Uses

Uses

• temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions And Dosage

Directions

• do not use more than directed • measure the dose correctly using the enclosed dosing cup • take every 4 hours in dosing cup provided, while symptoms persist • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use

Other Label Information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

1-800-452-0051

Principal Display Panel

NDC 0067-8127-08 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • COUGH • NASAL CONGESTION • SORE THORAT PAIN • FEVER • HEADACHE • BODY ACHE 8.3 FL OZ (245.5mL) Alcohol Free * Maximum Strength per 4 hour dose. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. 13271

Products

NDC Codes

Ingredients

NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
WATER059QF0KO0RIACT

Complete SPL Sections

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not use more than directed • measure the dose correctly using the enclosed dosing cup • take every 4 hours in dosing cup provided, while symptoms persist • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use

Other information

OTHER SAFETY INFORMATION

• each 30 mL contains : potassium 35 mg, sodium 17 mg • store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

OTC - QUESTIONS SECTION

1-800-452-0051

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-8127-08 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • COUGH • NASAL CONGESTION • SORE THORAT PAIN • FEVER • HEADACHE • BODY ACHE 8.3 FL OZ (245.5mL) Alcohol Free * Maximum Strength per 4 hour dose. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. 13271

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/ff48b55a-0d32-47d6-941d-d99c7cf52f94/5239b4c6-3ff8-4309-88c1-800335104e40.xml
XML SHA-256
e2066a3d0c33bed385b9b3092b8968e55180c1c1bb963c8d0a1d2b88d38401d9
XML bytes
35035

Legacy File Index

FolderFileDate
otc5239b4c6-3ff8-4309-88c1-800335104e40.xml2024-02-14
otc13411_Theraflu ExpressMAX DT SCC_8.3 OZ.JPG.jpg.jpg.jpg2022-04-28
otc83aacea7-68a1-494d-b36c-6d72a1e61584.xml2022-04-28
otc13411_Theraflu ExpressMAX DT SCC_8.3 OZ.JPG.jpg.jpg2020-12-16
otc1c91de77-8746-47f3-80fe-67701ab4c90a.xml2020-12-16
otc13411_Theraflu ExpressMAX DT SCC_8.3 OZ.JPG.jpg2019-04-04
otcf7c9686f-ac66-4d41-9b12-cff79e0cd353.xml2019-04-04