SLEEP AID NIGHTTIME- diphenhydramine hydrochloride capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
MEIJER, INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid For relief of occasional sleeplessness.
Authorization status:
OTC monograph final
Authorization number:
41250-659-32, 41250-659-64

SLEEP AID NIGHTTIME- diphenhydramine hydrochloride capsule

MEIJER, INC.

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.

----------

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpos e

Nighttime sleep-aid

Us es

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 older: 1 softgel (50 mg) at bedtime if needed, or as directed

by a doctor

Other information

store between 15-30ºC (59-86ºF)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified

water, sorbitan*, sorbitol

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Unisom® SleepGels®*

MAXIMUM STRENGTH

Sleep Aid

Diphenhydramine HCl | 50 mg

Nighttime Sleep-Aid

Safe, non-habit forming

SOFTGELS

ONE SOFTGELS PER DOSE

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

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

OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Product Label

MEIJER Maximum Streng th Sleep Aid

SLEEP AID NIGHTTIME

diphenhydramine hydrochloride capsule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -6 59

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

MEIJER, INC.

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

CAPSULE

S iz e

13mm

Flavor

Imprint Code

P50 ;A9 9 ;D50 ;AP0 18

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:41250 -6 59 -

1 in 1 BOX

0 4/30 /20 19

1

32 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:41250 -6 59 -

1 in 1 BOX

0 4/30 /20 19

2

6 4 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt338

0 4/30 /20 19

Labeler -

MEIJER, INC. (006959555)

Revised: 11/2019

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