Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Theraflu Syrup
FDA Label NDC 0067-0104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Theraflu (NDC 0067-0104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 30 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/Fever reducer
Cough suppressant
Expectorant
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- 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
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 a 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
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain or cough 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
- 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
- each 30 mL contains: potassium 30 mg, sodium 13 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions Or Comments?
1-855-328-5259
Generic Section
Distributed by: Haleon, Warren, NJ 07059. Made in Canada
Trademarks are owned by or licensed to the Haleon group of companies.
©2023 Haleon group of companies or its licensor. Pat. Info www.productpats.com 62000000207727
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DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
Package/Label Principal Display Panel
MULTI-SYMPTOM COLD RELIEF
NEW FORMULA
THERAFLU
SEVERE
COLD RELIEF
+ CHEST CONFESTION
Acetaminophen
Pain reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Guaifenesin / Expectorant
DAYTIME FORMULA
Powerful formula that relieves:
/ Chest congestion
/ Thins and loosens mucus
/ Head and body ache
/ Fever
/ Cough
/ Sore throat pain
8.3 FL OZ (245.5 mL)
Berry Flavor
PARENTS:
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62000000207725
Theraflu Scrcc Day 8oz (Therafluscrccday8oz.jpg)
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