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NDC 49035-0935-32 Sleep Aid 50 mg/1 Details

Sleep Aid 50 mg/1

Sleep Aid is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC). The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 49035-0935-32
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	49035-0935
Product ID	49035-935_d7d59113-ba37-431c-950a-39ef82307131
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	Sleep Aid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART 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	n/a

Package

Package Images

NDC 49035-0935-32 (49035093532)

Pricing Information	N/A
NDC Package Code	49035-935-32
Billing NDC	49035093532
Package	1 BOTTLE, PLASTIC in 1 BOX (49035-935-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f1bf058a-b2e4-44d7-99d7-55013e2c692d Details

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for 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 a 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. (1-800-222-1222)

Directions

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

Other information

store at 15-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan

*may contain this ingredient

Principal Display Panel

Compare to Unisom® SleepGels® Active Ingredient**

Maximum Strength

Sleep-Aid Softgels

Diphenhydramine HCI 50 mg

Nighttime sleep-aid

Fall asleep fast
Sleep soundly
Wake up refreshed

Liquid Filled

Safe, Non Habit-Forming

One softgel per dose

SOFTGELS

For Questions or comments or to report an undesired reactionor side effect, please call 1-888-287-1915.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

**This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

Package Label

EQUATE Maximum Strength Sleep-Aid Softgels

INGREDIENTS AND APPEARANCE

SLEEP AID

diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-935
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P50;A99;AP018
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-935-32	1 in 1 BOX	02/28/2018	12/27/2024
1		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:49035-935-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2018	12/27/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/28/2018	12/27/2024

Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)

Revised: 9/2022

Document Id: d7d59113-ba37-431c-950a-39ef82307131

Set id: f1bf058a-b2e4-44d7-99d7-55013e2c692d

Version: 4

Effective Time: 20220927