DIPHENHYDRAMINE HCL capsule, liquid filled

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Softech Pharma Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient in each Softgel

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Keep out of reach of Children

Uses

• for relief of occassional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products

Directions

Take only one dose per day (24 hours) - see Overdose warning

adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

Other Information

• store at 20-25˚C (68-77˚F)
• avoid excessive heat above 40˚C (104˚F) and high humidity
• protect from light

Inactive Ingredients

FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Diphenhydramine Hydrochloride Capsules, USP 25 mg

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48769-060
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	capsule	Size	7mm
Flavor		Imprint Code	R60
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48769-060-99	5000 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	01/01/2013

Labeler - Softech Pharma Pvt. Ltd (677111277)

Establishment
Name	Address	ID/FEI	Business Operations
Softech Pharma Pvt. Ltd		677111277	manufacture(48769-060)