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 Cardinal Health 110, LLC. DBA Leader, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

• in 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

• use caution when driving a motor vehicle or operating machinery
  
• drowsiness will occur
• 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 (1-800-222-1222) right away.

Directions

• do not take more than directed
• adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
• children under 12 years: do not use

Other information

• each caplet contains: calcium 30 mg
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  
• protect from moisture
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

NDC: 70000-0244-1

LEADER™

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

Helps You Fall Asleep

Does NOT Contain Pain Reliever

Non- Habit Forming

24 CAPLETS

ACTUAL SIZE

COMPARE TO SIMPLY SLEEP® active ingredient*

100% Money Back Guarantee

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

✓All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313
Essential to Care™ since 1979

© 2017 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health.

*This product is not manufactured or distributed by Johnson & Johnson, owner of the trademark Simply Sleep®.

50844      ORG051636708

Leader 44-367

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0244
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;367
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0244-1	2 in 1 CARTON	06/10/2000	04/10/2022
1		12 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 FINAL	part338	06/10/2000	04/10/2022

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(70000-0244)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(70000-0244)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(70000-0244) , PACK(70000-0244)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(70000-0244)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(70000-0244)