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FDA LABEL GENERIC: Acetaminophen MFR: Haleon US Holdings LLC

Apap 325 Mg / Diphenhydramine Hydrochloride 12.5 Mg Chewable Tablet

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

INDICATIONS AND USAGE

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

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. 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.

DOSAGE AND ADMINISTRATION

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

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)

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

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

FASTrelief ANYWHERE

fever / cough / headache / body aches / sore throat / runny nose / sneezing / watery eyes

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

Apple Cinnamon Flavor