NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled 
BJWC (Berkley & Jensen / BJ's)

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BJs 613T Diphenhydramine Hydrochlroide 25 mg Liquid

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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 emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • avoid alcoholic beverages

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 (1-800-222-1222) right away.

Directions

adults & children 12 yrs & over

2 softgels at bedtime if needed or as directed by a doctor

children under 12 yrs

do not use

Other information

Inactive ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, glycerol, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Questions or comments? Call 1-877-290-4008

613T-BJ- Nighttime sleep aid 192ct carton

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-613
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN (UNII: 6O92ICV9RU)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SHELLAC (UNII: 46N107B71O)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorpurple (Purple, Translucent) Scoreno score
ShapeCAPSULE (Oblong shaped) Size16mm
FlavorImprint Code 121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-613-9216 in 1 CARTON08/20/2025
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01008/20/2025
Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(68391-613)

Revised: 8/2025
Document Id: 3c10ec86-2536-00f5-e063-6394a90a244c
Set id: 2f476647-5727-3443-e063-6394a90afd3f
Version: 2
Effective Time: 20250819
 
BJWC (Berkley & Jensen / BJ's)