SLEEP AID- diphenhydramine hcl tablet, film coated

Sleep Aid by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

• for 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 emphysema or chronic bronchitis
  
• difficulty in urination due to enlargement of the prostate gland
  
• glaucoma
  

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• do not exceed recommended dosage
• 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
• adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
• children under 12 years: do not use

Other information

• each tablet contains: calcium 30 mg
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from moisture
  
• see end flap for expiration date and lot number
  

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Principal display panel

Since 1903
Rexall™

Sleep-Aid
Diphenhydramine HCl, 25 mg
Nighttime Sleep-Aid

Non-habit forming
Dye free
Not for treating
  Pain, Cold or Flu

Actual
Size

100
Tablets

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

50844 ORG102061412
Visit us at: Rexall.com
or call 1-866-4-REXALL

DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA
Since 1903 Rexall™ is a registered
trademark of Rexall Sundown, Inc.

Rexall 44-614

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-614
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
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;614
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-614-12	1 in 1 CARTON	07/10/2024
1		100 in 1 BOTTLE, PLASTIC; 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	07/10/2024

Labeler - DOLGENCORP, LLC (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(55910-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(55910-614) , pack(55910-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(55910-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(55910-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(55910-614)