Label: THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
- NDC Code(s): 0067-8137-10, 0067-8137-20
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 7, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Liver warning:This product contains acetaminophen. Severe lever 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.
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.
- Directions
- Other information
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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
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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
- NASAL CONGESTION • SORE THROAT • FEVER • BODY ACHE
- RUNNY NOSE • HEADACHE • COUGH • SNEEZING
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.
62000000010602
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INGREDIENTS AND APPEARANCE
THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8137 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength 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 Color blue Score no score Shape OVAL (caplet) Size 18mm Flavor MINT Imprint Code 1143N Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8137-20 2 in 1 CARTON 07/05/2016 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0067-8137-10 1 in 1 CARTON 06/08/2017 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/05/2016 Labeler - Haleon US Holdings LLC (079944263)
