SLEEPAID (DIPHENHYDRAMINE HCL)- diphenhydramine hcl capsule, liquid filled 
APNAR PHARMA LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SleepAid (Diphenhydramine Hydrochloride 50mg Capsule,Liquid Filled)

DRUG FACTS

Active ingredient (in each soft gel)

Diphenhydramine HCL 50 mg

Purpose

Nighttime sleep-aid

USES

Use for relief of occasional sleeplessness.

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF THE REACH OF CHILDREN.

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

Directions

adults and children 12 years of age and over: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

*Compare to active ingredient in Unisom ® SleepGels ®

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ®

Rev.: 03/2023

Manufactured by:

Apnar Pharma LLP

East Windsor, NJ 08520

NDC 24689-154-01

SleepAid

Diphenhydramine HCL 50 mg

Made in USA

100 Soft gels

SleepAid-Diphenhydramine HCL Capsule-50 mg-label

SLEEPAID (DIPHENHYDRAMINE HCL) 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-154
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITAN (UNII: 6O92ICV9RU)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code AD1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-154-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01005/04/2023
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917manufacture(24689-154) , analysis(24689-154) , pack(24689-154)

Revised: 5/2023
Document Id: faaf5d51-d81e-3acc-e053-6294a90ae08f
Set id: faaf5d51-d81d-3acc-e053-6294a90ae08f
Version: 1
Effective Time: 20230502
 
APNAR PHARMA LP