Active Ingredient

Acetaminophen 325 mg and Diphenhydramine HCl 12.5 mg

Purposes

Pain Reliever/Fever Reducer
Antihistamine

Uses

Temporarily reduces fever and relieves minor aches and pain caused by

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common cold

•

headache

•

toothache

•

muscular aches

•

backache

•

arthritis

•

flu

•

premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

•

adult or child 12 years and older takes more than 8 tablets in less than 24 hours which is the maximum daily amount

•

taken with other drugs containing acetaminophen

•

adult has 3 or more alcoholic drinks everyday while using this product.

 

Do not use

•

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 drug containing diphenhydramine, even one used on skin

 

Ask a doctor before use if the user has

•

liver disease

•

glaucoma

•

a breathing problem such as emphysema or chronic bronchitis

•

trouble urinating due to an enlarged prostate gland

 

Ask a doctor or pharmacist before use if the user is.

•

taking the blood thinning drug warfarin

•

taking sedatives or tranquilizers

 

When using this product

•

you may get very drowsy

•

avoid alcoholic drinks

•

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

•

pain gets worse or lasts more than 10 days

•

fever gets worse or lasts more than 3 days

•

redness or swelling is present

•

any new symptoms appear

 

If pregnant or breast feeding, ask a health professional before use.

 

Keep out of reach of children.

 

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

•

adults and children 12 years & over: take 2 tablets every 4 hours, but not more than 8 tablets in 24 hours

•

children under 12 years: do not use

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 (al-lake), hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, titanium dioxide.

QUESTIONS

Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100 Tablets

NDC 0536-3605-01

Rugby

Acetaminophen 325 mg / Diphenhydramine HCl 12.5 mg

Pain Reliever, Fever Reducer, Antihistamine