Diphenhydramine Hydrochloride 25 MG Oral Capsule

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Drug Information

Imprint:	R60
Shape:	C48336
Color:	C48327
Ingredients:	Diphenhydramine
Size:	7.00
Score:	1
Rxtty:	SCD
Author:	Softech Pharma Pvt. Ltd
Inactive Ingredients:	FD&C BLUE NO. 1 / FD&C RED NO. 40 / GELATIN / GLYCERIN / METHYLPARABEN / POLYETHYLENE GLYCOL 400 / PROPYLPARABEN / WATER / SORBITOL / TITANIUM DIOXIDE>

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 20-25ËšC (68-77ËšF)
- avoid excessive heat above 40ËšC (104ËšF) 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 HCLÂ
diphenhydramine hcl capsule, liquid filled

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

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	Â
FD&C RED NO. 40 (UNII: WZB9127XOA)	Â
GELATIN (UNII: 2G86QN327L)	Â
GLYCERIN (UNII: PDC6A3C0OX)	Â
METHYLPARABEN (UNII: A2I8C7HI9T)	Â
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	Â
PROPYLPARABEN (UNII: Z8IX2SC1OH)	Â
WATER (UNII: 059QF0KO0R)	Â
SORBITOL (UNII: 506T60A25R)	Â
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	Â

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

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

Labeler -Â Softech Pharma Pvt. Ltd (677111277)

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