DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule, liquid filled 
Gobrands, Inc

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NIGHTTIME

Sleep Aid

Diphenhydramine HCl

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

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 & overOne dose = TWO 25 mg softgels (50 mg) at
bed time if needed or as directed by a doctor
children under 12 yearsdo 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

Carton

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82501-1578
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScoreno score
ShapeOVALSize15mm
FlavorImprint Code 602
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82501-1578-21 in 1 CARTON05/16/2022
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01005/16/2022
Labeler - Gobrands, Inc (057499049)
Registrant - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c04ef09-109f-4c9f-e063-6394a90a3bbf
Set id: 11b7c200-b79f-4e35-9d53-00f021fa43b0
Version: 4
Effective Time: 20231208
 
Gobrands, Inc