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NDC 49035-0237-16 NIGHTTIME SLEEP AID Maximum Strength 50 mg/1 Details

NIGHTTIME SLEEP AID Maximum Strength 50 mg/1

NIGHTTIME SLEEP AID Maximum Strength is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Walmart Stores, Inc.). The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

Product Information

NDC	49035-0237
Product ID	49035-237_b65203a1-0b17-493b-a0f3-b8315d739bf7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	NIGHTTIME SLEEP AID Maximum Strength
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	EQUATE (Walmart Stores, Inc.)
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0237-16 (49035023716)

Pricing Information	N/A
NDC Package Code	49035-237-16
Billing NDC	49035023716
Package	1 BOTTLE, PLASTIC in 1 CARTON (49035-237-16) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2013-10-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2b1af499-623e-4f6a-949b-21abf276b65d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

for the relief of occasional sleeplessness

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
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 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 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 adoctor

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

Call toll free 1-888-287-1915

PRINCIPAL DISPLAY PANEL - 32ct Carton and Bottle Label

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 32 Softgels

Compare to Unisom® SleepGels® Active Ingredient*

NDC 49035-237-16

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

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

PRINCIPAL DISPLAY PANEL - 96ct Bottle Label

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 96 Softgels

Compare to Unisom® SleepGels® Active Ingredient*

NDC 49035-237-96