THERAFLU EXPRESSMAX  NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hcl, phenylephrine hcl syrup 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

Do not use

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on the skin
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. 30 mL
  1. children under 12 years of age
  1. do not use

Other 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 0067-8129-08

THERAFLU

ExpressMax

NIGHTTIME

SEVERE COLD & COUGH

BERRY FLAVOR

ACETAMINOPHEN

PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl

ANTIHISTAMINE/COUGH SUPPRESSANT

PHENYLEPHRINE HCl

NASAL DECONGESTANT

• COUGH • NASAL CONGESTION

• SORE THORAT PAIN • FEVER

• HEADACHE • BODY ACHE

• RUNNY NOSE

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.

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13414_Theraflu ExpressMAX NT SCC_8.3 OZ.JPG
THERAFLU EXPRESSMAX   NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8129-08245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/15/2015
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 131827e6-0141-cf1d-e063-6294a90ae248
Set id: f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb
Version: 7
Effective Time: 20240307
 
Haleon US Holdings LLC