ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Cispharma, Inc
Cispharma, Inc

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE CAPLETS

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
• ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Uses
• Warnings
• Overdasage Warnings;
• Directions: do not take more than directed (see overdose warning)
• Other Information
• Inactive Ingredients

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen ..............................500 mg

Diphenhydramine HCl ......................25 mg

Purpose

Pain Reliver

Nighttime Sleep Aid

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Uses

temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 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 product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

■ liver disease; ■ a breathing problem such as emphysema or chronic bronchitis; ■ trouble urinating due to an enlarged prostate gland; ■ glaucoma

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin; ■ taking sedatives or tranquilizers

When using this product■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery.

Stop use and ask a doctor if

■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. ■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days ■ redness or swelling is present

■ new symptoms occur

These could be signs of a serious condition.

Uses

Indicated for pain relief and night time sleep aid.

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

Keep out of reach of children.

Overdasage Warnings;

Taking more than the recommended dose (overdose) may liver damage. In case of overdose, get medical help or contact poison control center right away. 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)

Other Information

• store between 20°- 25°C (68°- 77°F)
• do not use if the box is opened

Inactive Ingredients

Carnauba wax, FD&C blue # 1 al lake, FD&C blue # 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin

*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol® PM

Questions or Comments?
Call 1-866-383-9908

Manufactured by:

Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512