EZ NITE SLEEP- diphenhyramine hydrochloride capsule, liquid filled 
KROGER COMPANY

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Kroger Diphenhydramine Hydrochloride 25 mg Softgels

Drug Facts

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.

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 aretaking sedatives or tranquilizers

When using this product
■ avoid alcoholic beverages

Stop use and ask a doctor ifsleeplessness 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

■ take only one dose per day (24 hours)


adults & children 12 yrs & over
2 softgels at bedtime if needed or as directed by a doctor
children under 12 yrsdo not use

Other information

■ store at 20-25° C (68-77°F)
■ avoid excessive heat above 40°C (104°F)
■ protect from light

Inactive ingredients

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

Questions or comments? Call 1-800-632-6900

diphenhydramine-sg-24s-ifc

EZ NITE SLEEP 
diphenhyramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-613
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SHELLAC (UNII: 46N107B71O)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colorpurple (Purple,translucent) Scoreno score
ShapeCAPSULE (oblong shaped) Size16mm
FlavorImprint Code 121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-613-242 in 1 CARTON04/15/2024
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 DrugM01004/15/2024
Labeler - KROGER COMPANY (006999528)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-613)

Revised: 4/2024
Document Id: 16443f3d-c881-1fe3-e063-6394a90a4e4d
Set id: 0fec16a4-b4eb-8f8f-e063-6394a90a7327
Version: 2
Effective Time: 20240417
 
KROGER COMPANY