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

SleepAid (Diphenhydramine HCL) by

Drug Labeling and Warnings

SleepAid (Diphenhydramine HCL) by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, APNAR PHARMA LLP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient (in each soft gel)

Diphenhydramine HCL 50 mg

PURPOSE

Purpose

Nighttime sleep-aid

INDICATIONS & USAGE

USES

Use for relief of occasional sleeplessness.

WARNINGS

Warnings

Do not use

• for children under 12 years of age
• with any other products 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
• trouble urinating due to an enlarged prostate gland.

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 REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• store at room temperature 15º to 30º C (59º to 86º F)
• avoid excessive heat
• do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT

Inactive Ingredients

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

QUESTIONS

Questions or comments?

• Call 1-855-642-2594

SPL UNCLASSIFIED SECTION

*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

PRINCIPAL DISPLAY PANEL

NDC: 24689-154-01

SleepAid

Diphenhydramine HCL 50 mg

• Safe, non habit-forming
• One softgel per dose

Made in USA

100 Soft gels

INGREDIENTS AND APPEARANCE

SLEEPAID (DIPHENHYDRAMINE HCL) 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-154
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	AD1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-154-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M010	05/04/2023

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	manufacture(24689-154) , analysis(24689-154) , pack(24689-154)