THERAFLU EXPRESSMAX SEVERE COLD AND FLU CAPLETS- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

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Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

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.
  • 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
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chromic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

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, carmine, croscarmellose sodium, crospovidone, ethanol, ferric oxide yellow, flavors, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, titanium dioxide

Questions or Comments?

call 1-855-328-5259

Package/Label Principal Display Panel

NDC 0067-8145-01

Theraflu®Expressmax

SEVERE COLD AND FLU

NEW!

WARMING RELIEF FORMULA

ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER

DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT

GUAIFENESIN- EXPECTORANT

PHENYLEPHRINE HCl- NASAL DECONGESTANT

12982_Theraflu expressmax cold and flu caps_20ct.jpg
THERAFLU EXPRESSMAX SEVERE COLD AND FLU CAPLETS 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8145
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARMINIC ACID (UNII: CID8Z8N95N)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
ALCOHOL (UNII: 3K9958V90M)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
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
ColorredScoreno score
ShapeOVAL (Capsule shaped) Size19mm
FlavorMINTImprint Code IL5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8145-012 in 1 CARTON07/17/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/17/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263)
Registrant - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Mallinckrodt, Inc.097722284api manufacture(0067-8145)
Establishment
NameAddressID/FEIBusiness Operations
DIVI's Laboratories Limited918598199api manufacture(0067-8145)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918457644api manufacture(0067-8145)

Revised: 11/2023
Document Id: 0995a0e7-dcd7-66d7-e063-6394a90ac7d0
Set id: 8e22f6bc-33ce-4bb0-99be-7947aa21f60e
Version: 3
Effective Time: 20231107
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.