DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Gobrands, Inc, Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

● for the relief of occasional 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

Ask a doctor before use if you have ● a breathing problem such as asthma, emphysema, or chronic bronchitis ● glaucoma ● difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use ifyou are taking sedatives, tranquilizers or any other sleep aid

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

take only one dose per day (24 hours)

• adults & children 12 years & over: One dose = TWO 25 mg softgels (50 mg) at ; bed time if needed or as directed by a doctor
• children under 12 years: do not use

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 No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82501-1578
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)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82501-1578-2	1 in 1 CARTON	05/16/2022
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	05/16/2022

Labeler - Gobrands, Inc (057499049)

Registrant - Spirit Pharmaceuticals LLC (179621011)