NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled

Nighttime Sleep-Aid by

Drug Labeling and Warnings

Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by BIONPHARMA INC., Bionpharma Inc., SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• For 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 product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• 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
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuosly for more than 2 weeks, consult your doctor.

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 Centre right away.

Directions

• Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
• swallow whole; do not crush, chew, or dissolve

Other information

• store at 20 oC to 25 oC (68 oF to 77 oF)
• avoid high humidity and excessive heat above 40 oC (104 oF).
• protect from light

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-888-235-2466(Mon-Fri 9AM-5PM EST)

SPL UNCLASSIFIED SECTION

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

This product is not manufactured or distributed by the owners of Unisom ® SleepGels ®.

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

Made in India

L0000778

R0124

Mfg. Lic. No.: TN00002123

2620515

Lot No.:

Exp. Date:

160's count

Compare to the active ingredient in Unisom ®SleepGels ®

NDC: 69452-427-79

a+ health

maximum strength

nighttime

sleep-aid

diphenhydramine HCl capsules USP, 50 mg

fall asleep fast

sleep soundly

safe, non-habit

forming

one softgel per dose

160 softgels**

**liquid-filled capsules

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-427
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
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SORBITAN (UNII: 6O92ICV9RU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	B50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-427-79	160 in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2024
2	NDC: 69452-427-17	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2024
3	NDC: 69452-427-10	32 in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	03/21/2024

Labeler - BIONPHARMA INC. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(69452-427)