ACETA-GESIC by Rugby Laboratories / TIME CAP LABS, INC. / TIME-CAP LABS, INC

ACETA-GESIC by

Drug Labeling and Warnings

ACETA-GESIC by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, TIME CAP LABS, INC., TIME-CAP LABS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETA-GESIC- acetaminophen and diphenhydramine hydrochloride tablet, coated 
Rugby Laboratories

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: 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 other product containing diphenhydramine, even one used on skin

Ask doctor or pharmacist before use if you are:

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

Ask a doctor before use if you have

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

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); conditions worsen 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 advice of a health professional before using this product.

Keep this and all drugs out of the reach of children

Directions:

• adults and children 12 years and over: take 1 or 2 tablets every six hours while symptoms last. Maximum daily dose is 8 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

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

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

Each tablet contains:

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Pain Reliever-Fever Reducer-Antihistamine

Warnings:

Liver warning: This product contains acetaminophen. Sever liver damage may occur if: adult or child 12 years and older takes more than 8 tablets in 24 hours, which is the maximum daily amount; taking with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.

ACETA-GESIC 
acetaminophen and diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1003
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 (15 MPA.S AT 5%) (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, 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: 0536-1003-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2014	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/30/2014	12/31/2018

Labeler - Rugby Laboratories (079246066)

Registrant - TIME CAP LABS, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME-CAP LABS, INC		037052099	MANUFACTURE(0536-1003)

Revised: 1/2020

Document Id: ba651e6f-3fd6-4891-8d1e-714430a839d2

34390-5

Set id: d94be01d-82b4-4419-8f12-e76b5c92f52d

Version: 3

Effective Time: 20200129