356R APAP/DIPHEN hcl tABS 325/12.5 ORANGE FC CLEAR DailyMed Label

Key Label Information

Active Ingredients And Purpose

OTC - PURPOSE SECTION

Pain Reliever-fever reducer-antihistamine

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains: acetaminophen 325 mg diphenhydramine HCl 12.5 mg

Uses

INDICATIONS & USAGE SECTION

Uses: temporarily releives mnor aches and pains due to: headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.

Warnings

OTC - DO NOT USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or nursing, as with any drug, seek the advise of a health professional before using this product.

WARNINGS SECTION

Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult or child 12 years and older takes more than 12 tablets in 24 hours, which is the maximum daily amount; taking with other durgs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions adults and children 12 years and over: take 1 to 2 tablets every six hours while symptoms last. Maximum daily dose is 9 tablets in 24 hours unless directed by a doctor. children under 12 years: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Label Information

STORAGE AND HANDLING SECTION

Other information store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F) use by expiration date on package avoid excessive heat sodium free

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, crospovidone, fd&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid

Products

TIME-GESIC
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE

NDC Codes

Ingredients

Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSPOVIDONE	68401960MK	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, PREGELATINIZED CORN	O8232NY3SJ	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

Complete SPL Sections

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease.

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 - STOP USE SECTION

Stop use and ask a doctor if pain persists for more than 10 days; fever persists for more than 3 days (unless directed by a doctor); condition worsens or new symptoms appear; redness or swelling is present. These could be signs of a serious condition.