Diphenhydramine by Rebel Distributors Corp DIPHENHYDRAMINE capsule

Diphenhydramine by

Drug Labeling and Warnings

Diphenhydramine by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Diphenhydramine HCl 25mg

Diphenhydramine HCl 50mg

Purpose

Antihistamine

Keep Out of Reach of Children

Uses

Temporarily relieves: ° hay fever or other upper respiratory allergies like: ° runny nose

° sneezing ° watery eyes ° itchy nose or throat

Warnings

Do not use with any other product containing Diphenhydramine HCl, including one applied topically.

Ask a doctor or pharmacist before use if you have ° trouble urinating due to enlarged prostate gland ° a breathing problem such as emphysema or chronic bronchitis ° glaucoma ° if you are taking sedatives or tranquilizers

When using this product ° avoid alcoholic drinks ° marked drowsiness may occur ° excitability may occur, especially in children ° alcohol, sedatives & tranquilizers may increase drowsiness ° be careful when driving a motor vehicle or operating machinery.

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

° take every 4-6 hours

° do not take more than 6 doses in 24 hours.

Adults & children 12 years & over: 1-2 capsules

Children 6 to under 12 years: 1 capsule

Children under 6: ask a doctor

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Protect from excessive moisture

Inactive ingredients

Lactose Monohydrate, Silicon Dioxide, Magnesium Steareate, Black Iron Oxide, Gelatin, Sodium Lauyl Sulfate, D&C Red No. 28, FD&C Red No. 40, FD&C Blue No. 1.

Distributed by:

SDA Laboratories, Inc.

Greenwich, CT 06830

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE 
diphenhydramine capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-304(NDC:66424-020)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	PINK (Pink/White)	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	PH;014
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-304-15	15 in 1 BOTTLE
2	NDC: 21695-304-20	20 in 1 BOTTLE
3	NDC: 21695-304-24	24 in 1 BOTTLE
4	NDC: 21695-304-30	30 in 1 BOTTLE
5	NDC: 21695-304-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2007

DIPHENHYDRAMINE 
diphenhydramine capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-500(NDC:66424-021)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	PH;013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-500-15	15 in 1 BOTTLE
2	NDC: 21695-500-20	20 in 1 BOTTLE
3	NDC: 21695-500-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2007

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK