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

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Drug Facts

Active ingredient

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

Warnings

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

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

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.

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

Other information

Inactive ingredients

benzoic acid, croscarmellose sodium, ethanol, FD&C blue no.2 aluminum lake, ferrosoferric oxide, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicone dioxide, stearic acid, sucralose, titanium dioxide

Questions or comments?

call 1-800-452-0051

Principal Display Panel

NDC 0067-8137-20

Theraflu ®Express Max ®

NIGHTTIME

SEVERE COLD & COUGH

WARMING RELIEF™ FORMULA

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT

PEHNYLEPHRINE HCl – NASAL DECONGESTANT

20 COATED CAPLETS

*Maximum Strength per 4 hour dose.

TAMPER EVIDENT FEATURE:

THERAFLU ®EXPRESSMAX ®CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2016 GSK group of companies or its licensor. All rights reserved.

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THERAFLU EXPRESSMAX   NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8137
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVAL (caplet) Size18mm
FlavorMINTImprint Code 1143N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8137-202 in 1 CARTON07/05/2016
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0067-8137-101 in 1 CARTON06/08/2017
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/05/2016
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 13185fea-1e12-cf5a-e063-6394a90a18af
Set id: 62f7fcb9-e31a-4634-b1c2-44a9567e3a61
Version: 3
Effective Time: 20240307
 
Haleon US Holdings LLC