NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled
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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.

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Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for the 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 other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

a breathing problem such as asthma, 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 beverages

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. (1800-222-1222)

Directions

take only one dose (2 softgels) per day (24 hours)
swallow whole; do not crush, chew, or dissolve
adults & children 12 yrs and over
- take 2 softgels at bedtime, if needed or as directed by a doctor
children under 12 years of age: do not use

Other information

store between 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F) and high humidity
protect from light

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol*, purified water, sorbitan, sorbitol

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

Compare to Vicks® ZZZQuil® active ingredient**

See Warnings

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Helps You Fall Asleep

Non Habit-Forming
Not For Treating Cold or Flu

SOFTGELS

**This product is not manufactured or distributed by The Procter & Gamble Company, Vicks® and Zzzquil™ are registered trademarks of The Procter & Gamble Company.

Failure to follow these warnings could result in serious consequences.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

MADE WITH PRIDE AND CARE FOR

H-E-B®, SAN ANTONIO, TX 78204

Product Label

H-E-B Nighttime Sleep-Aid

NIGHTTIME SLEEP AID
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-104
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	A41;602
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37808-104-24	24 in 1 CARTON	12/31/2014	01/05/2024
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	12/31/2014	01/05/2024

Labeler - H E B (007924756)

Revised: 10/2021

Document Id: e1ca366d-fd4a-4afa-9874-31a2419e281f

Set id: cc019900-402c-433f-a2a3-70281ef996c9

Version: 5

Effective Time: 20211015

H E B