ALLER-G-TIME - diphenhydramine hydrochloride tablet, film coated
TIME CAP LABORATORIES, 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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ACTIVE INGREDIENTS:

In each tablet : DIPHENHYDRAMINE HCL

PURPOSE: ANTIHISTAMINE

Keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS AND USAGE:

TEMPORARILY RELIEFSTHESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES:

RUNNING NOSE, ITCHY, WATERY EYES, SNEEZING, ITCHY NOSE OR THROAT

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO THE COMMON COLD: RUNNY NOSE, SNEEZING

Do not use to make a child sleepy; with any other product containing diphenhydramine, even one used on skik

Directions - take every 4 t0 6 hours.
Do not take more than 6 doses in 24 hours.
adults and children 12 years of age and older - 1 to 2 caplets
children 6 to under 12 years of age - 1 caplet
children under 6 years of age - do not use this product in children under 6 years of age

carnauba wax, colloidal silicon dioxide, d-c red no 27 aluminum lke, dibasic calcium phosphate dehydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-PEG-400, polysorbate80, titanium dioxide.

160R Enter section text here

ALLER-G-TIME
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-061
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	T061
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49483-061-01	100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC	None
2	NDC:49483-061-10	1000 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2012

Labeler - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Operations
TIME CAP LABORATORIES, INC		037052099	manufacture

Revised: 05/2012 TIME CAP LABORATORIES, INC