Label: THERAFLU EXPRESSMAX SEVERE COLD AND FLU SYRUP- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl syrup
- NDC Code(s): 0067-8132-08
- 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 ingredients (in each 30 mL)
- Purposes
-
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
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these symptoms due to a cold:
-
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.
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, chronic bronchitis or emphysema
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
- 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
- Inactive ingredients
- Questions or Comments?
-
Package/Label Principal Display Panel
NDC 0067-8132-08
Theraflu®Expressmax ™
SEVERE COLD AND FLU
ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT
GUAIFENESIN- EXPECTORANT
PHENYLEPHRINE HCl- NASAL DECONGESTANT
- BODY ACHE
- FEVER
- CHEST CONGESTION
- NASAL CONGESTION
- HEADACHE
- COUGH
- SORE THROAT PAIN
ALCOHOL FREE
BERRY FLAVOR 8.3 FL OZ (245.5 mL)
- PARENTS:
- Learn about teen medicine abuse
- www.StopMedicineAbuse.org
- *Maximum Strength per 4 hour dose.
- Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
- Trademarks are owned or licensed to the GSK group of companies.
- © 2016 GSK group of companies or its licensor. All rights reserved.
-
INGREDIENTS AND APPEARANCE
THERAFLU EXPRESSMAX SEVERE COLD AND FLU SYRUP
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8132 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 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) Product Characteristics Color red Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8132-08 1 in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/07/2017 Labeler - Haleon US Holdings LLC (079944263)
