Active Ingredients (In Each Chewable Tablet)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Theraflu Tablet, Chewable
FDA Label NDC 0067-0112
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 0067-0112). 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 chewable tablet), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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
Antihistamine/Cough suppressant
Uses
▪ temporarily relieves these symptoms due to a cold:▪ minor aches and pains▪ sore throat pain▪ headache▪ runny nose▪ sneezing▪ itchy nose or throat▪ itchy, watery eyes due to hay fever▪ cough due to minor throat and bronchial irritation
▪ temporarily reduces fever
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 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
Ask A Doctor Before Use If You Have
▪ liver disease▪ 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
▪ 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
▪ 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▪ do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist.
Age | Dose |
adults and children 12 years of age and over | take 2 chewable tablets every 4 hours |
children under 12 years of age | do not use |
Other Information
▪ each chewable tablet contains: calcium 10 mg, potassium 10 mg, sodium, 7 mg▪ store at a controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients
brown iron oxide, calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk
Questionsor Comments?
call 1-855-328-5259
Generic Section
Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
Package/Label Principal Display Panel
NEW
THERAFLU
SEVERE COLD RELIEF
NIGHTTIME
Soft CHEWS
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine/Cough Suppressant
FAST relief ANYWHERE
fever / cough / headache / body aches / sore throat / runny nose / sneezing / watery eyes
20 CHEWABLE TABLETS
Chew tablets completely before swallowing
Apple Cinnamon Flavor
* Please review the disclaimer below.
