SLEEP-AID- diphenhydramine hcl tablet, chewable

Sleep-Aid by

Drug Labeling and Warnings

Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

• reduces time to fall asleep if you have difficulty falling asleep
• 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
• 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.

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.

Directions

• do not take more than directed
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• take only one dose per day (24 hours)
• adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
• children under 12 years: do not use

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• avoid high humidity
• see end flap for expiration date and lot number
  

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-800-426-9391

Principal display panel

FREE
FROM
CAFFEINE FREE

Compare to the active ingredient
in Unisom® Chewables*

NDC: 11822-0685-8

SLEEP-AID
DIPHENHYDRAMINE HCI, 25 mg
CHEWABLE TABLETS
nighttime sleep-aid
non-habit forming
not for treating pain, cold or flu

ACTUAL SIZE

Chew or crush
tablets completely
before swallowing.

ACTUAL SIZE

24
TABLETS

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

*This product is not manufactured or
distributed by Chattem, Inc., owner of the
registered trademark Unisom® Chewables.
50844           ORG011968508

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

SATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.

Rite Aid 44-685

INGREDIENTS AND APPEARANCE

SLEEP-AID 
diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0685
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	13mm
Flavor	GRAPE	Imprint Code	44;685
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0685-8	4 in 1 CARTON	06/16/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	06/16/2021

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	pack(11822-0685)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(11822-0685)