TIME-GESIC- acetaminophen and diphenhydramine hydrochloride tablet, coated

TIME-GESIC by

Drug Labeling and Warnings

TIME-GESIC by is a Otc medication manufactured, distributed, or labeled by Time-Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DO NOT USE

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.

ASK DOCTOR

Ask a doctor before use if you have liver disease.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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

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

INDICATIONS & USAGE

Uses: temporarily releives mnor aches and pains due to:

headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.

PURPOSE

Pain Reliever-fever reducer-antihistamine

WARNINGS

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.

ACTIVE INGREDIENT

Each tablet contains:

acetaminophen 325 mg

diphenhydramine HCl 12.5 mg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIME-GESIC 
acetaminophen and diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-356
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	TCL106
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-356-09	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/18/2012
2	NDC: 49483-356-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/18/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/18/2012

Labeler - Time-Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time-Cap Labs, Inc		037052099	manufacture(49483-356)