ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

Drug Facts

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purpose
Acetaminophen 500mg	Pain reliever
Diphenhydramine HCl 25mg	Nighttime Sleep aid

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur with this product if you take

• more than 2 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while you are using this product

OTC - DO NOT USE SECTION

Do not use

• with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• in children under 12 years of age
• with any other products containing diphenhydramine, even one used on skin
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• liver cirrhosis
• asthma
• breathing problems such as emphysema or chronic bronchitis
• trouble in urinating due to an enlargement of the prostate gland
• glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery.

OTC - STOP USE SECTION

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than recommended (see overdose warning)

adults and children 12 years of age and over:	take 2 caplets at bedtime or as directed by a doctor do not take more than 2 caplets in a 24 hour period
children under 12 years of age:	do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

• store at 20°-25°C (68°-77°F)
• see end panel for lot number and expiration
• each tablet contains: magnesium 0.05 mg

Inactive Ingredients

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide

Questions Or Comments?

1-888-287-1915

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

Principal Display Panel - 50 Caplet Bottle Carton

NDC 49035-026-50

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Extra Strength

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50CAPLETS

Actual Size