Label: THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr powder
- NDC Code(s): 0067-7922-02
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 16, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each packet)
- Purposes
- Uses
-
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
- glaucoma
- 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 or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- 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
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Directions
- do not use more than directed
- take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
Age
Dose
adults and children
12 years of age and over
one packet
children under
12 years of age
do not use
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz of cool water; stir briskly before and after heating. Do not overheat.
- Other information
- Inactive ingredients
- Questions or comments?
-
Additional Information
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
HOT LIQUID THERAPYthat relieves:
Fever
Body Ache
Headache
Sore Throat Pain
Cough
Runny Nose
Honey Lemon Flavor
*Maximum Strength per 6 hour dose
**Temporarily controls cough to help you rest. This is not a sleep-aid.
PARENTS:Learn about teen medicine abuse
www.StopMedicineAbuse.org
TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
1-855-297-3031
Distributed by: Haleon, Warren, NJ 07069
Trademarks are owned by or licensed to the
Haleon group of companies.
©2025 Haleon group of companies or its licensor.
62000000217489
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Principal Display Panel
MULTI-SYMPTOM FLU RELIEF
HALEON
THERAFLU
FLU RELIEF MAX STRENGTH*
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
HELPS YOU REST**
Hot liquid therapythat relieves:
/ Fever
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
/ Runny nose
Honey Lemon Flavor
6 PACKETS
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INGREDIENTS AND APPEARANCE
THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-7922 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SOYBEAN LECITHIN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color white (to off white, yellow, beige, and brown color) Score Shape Size Flavor HONEY (Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-7922-02 6 in 1 CARTON; Type 0: Not a Combination Product 06/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/15/2022 Labeler - Haleon US Holdings LLC (079944263)
