Label: THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr syrup
- NDC Code(s): 0067-8205-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL)
- Purposes
- Uses
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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
- 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
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Directions
- do not use more than directed
- measure the dose correctly using the enclosed dosing cup
- adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
- do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
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Additional Information
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
LIFT HERE
*Maximum Strength per 6 hour dose.
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Dist. by: GSK Consumer Healthcare
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Trademarks are owned by or licensed to the GSK group of companies.
Made in Canada
©2020 GSK group of companies or its licensor.
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Principal Display Panel
NDC 0067-8205-01
THERAFLU
FLU RELIEF
MAX STRENGTH*
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
Powerful fever fighting
formula that relieves:
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
/ Runny nose
Honey & Elderberry Flavor
8.3 FL OZ (245.5 mL)
1001488 Front Bottle Label
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INGREDIENTS AND APPEARANCE
THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8205 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) HONEY (UNII: Y9H1V576FH) PEG-10 .BETA.-SITOSTERYL ETHER (UNII: B2138XJ83G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM GLUCONATE (UNII: R6Q3791S76) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) Product Characteristics Color Score Shape Size Flavor BERRY (Elderberry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8205-01 245.5 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 06/27/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/27/2022 Labeler - Haleon US Holdings LLC (079944263)
