Acetaminophen, Diphenhydramine Hydrochloride (acetaminophen 500 mg diphenhydramine hydrochloride 12.5 mg) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever
Diphenhydramine HCl 12.5 mg	Antihistamine

Uses

• temporarily relieves:
  • runny nose
  • sneezing
  • itching of the nose or throat and itchy, watery eyes due to hay fever
  • headache
  • minor aches and pains

Warnings

Liver warning

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

• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day 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 product containing diphenhydramine, even one used on 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

Ask a doctor or pharmacist before use if you are

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

When using this product

• marked drowsiness may occur
• 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

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days

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.

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 directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 6 hours do not take more than 8 caplets in 24 hours
children under 12 years	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 between 20º-25ºC (68º-77ºF) in a dry place
• retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, copovidone, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048

Principal Display Panel - 24 Caplet Blister Pack Carton

NDC 57344-101-01

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^†COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® SEVERE ALLERGY

MAY CAUSE DROWSINESS

Severe Allergy Pain Reliever, Antihistamine

• Runny Nose
• Sneezing
• Itchy, Watery Eyes Diphenhydramine HCl
• Sinus Pain - Acetaminophen

24 CAPLETS