BENALDRYL- diphenhydramine hcl tablet

BENALDRYL by

Drug Labeling and Warnings

BENALDRYL by is a Otc medication manufactured, distributed, or labeled by AJES PHARMACEUTICALS,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

Diphenhydramine HCI USP 25 mg

PURPOSE

Purpose

Antihistamine

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

In case of accidental overdose,

seek professional assistance or contact a Poison Control Center

INDICATIONS & USAGE

Uses

-temporarily relieves these symptoms due to hay fever or upper

respiratory allergies: runny nose - sneezing - itchy, watery eyes

-itching of the nose and throat - temporarily relieves these

symptoms due to the common cold: runny nose - sneezing

WARNINGS

Warnings

Do Not Use - to make a child sleepy - with any other product

containing diphenhydramine, even one used on skin

DOSAGE & ADMINISTRATION

Directions - take every 4 to 6 hours

-do not take more than 6 doses in 24 hours

adults and children 12 years of age or older - 1 to 2 tablets

children 6 years to under 12 years of age - 1 tablet

children under 6 years of age  -  do not use this product in children under 6 years of age

INACTIVE INGREDIENT

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENALDRYL 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42787-104
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  in 250 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	C22
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42787-104-12	1 in 1 CARTON
1		25000 mg in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2012

Labeler - AJES PHARMACEUTICALS,LLC (159945393)

Establishment
Name	Address	ID/FEI	Business Operations
AJES PHARMACEUTICALS,LLC		159945393	manufacture(42787-104) , repack(42787-104) , relabel(42787-104)