TIME-GESIC- acetaminophen and diphenhydramine hydrochloride tablet, coated 
Time-Cap Labs, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Do not use

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are

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.

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

Keep this and all drugs out of reach of children.

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 information

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

Uses: temporarily releives mnor aches and pains due to:

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

Pain Reliever-fever reducer-antihistamine

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.

Each tablet contains:

acetaminophen 325 mg

diphenhydramine HCl 12.5 mg

356R LABEL

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 DEA Schedule     
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
COLLOIDAL 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
2 NDC:49483-356-00 100000 in 1 CARTON
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)

Revised: 1/2014
Document Id: 92884990-789c-40b6-a937-2b3da8c4a58f
Set id: 889c5b6a-879e-425c-a25a-435766e9d601
Version: 4
Effective Time: 20140113
 
Time-Cap Labs, Inc