ACETAINOPHEN AND DIPHENHYDRAMINE HCL TABLETS 500/25 mg

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness

Warnings

Alcohol Warnings

If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

• *with any other product containing acetaminophen
• *with any other product containing diphenhydramine, even one used on skin
• *in children under 12 years of age

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• *a breathing problem such as emphysema or chronic bronchitis
• *glaucoma
• *difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

ASK a doctor or pharmacists before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

• *do not exceed recommended dosage
• *avoid alcoholic beverages
• *marked drowsiness may occur
• *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 two weeks. Insomnia may be a symptom of a serious underlying medical illness
• *new symptoms occur
• *redness or swelling is present
• *pain gets worse or lasts more than 10 days
• *fever gets worse or lasts more than 3 days

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. In case of accidental 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.

Direction

• *use as directed
• *adults and children 12 years and over : take 2 caplets at bedtime or as directed by a doctor
• *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 could cause serious health problems.

Other information

• *Store at room temperature

Inactive ingredients

croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate,collodial silicon dioxide, FD & C blue # 1