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 Topco Associates, LLC, 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

Uses

• for relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin
• for children under 12 years of age
  
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema, or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• heart disease

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep aid.

When using this product

• avoid alcoholic beverages and other drugs that cause drowsiness
• drowsiness will occur
• use caution when driving a motor vehicle or operating machinery

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 (50 mg) at bedtime if needed, or as directed by a doctor
• children under 12 years: do not use

Other information

• each caplet contains: calcium 70 mg
• avoid excessive heat (greater than 100°F) or humidity
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal display panel

TopCare®
       Health™

NDC: 36800-672-06

COMPARE TO 
VICKS® ZZZQUIL™
ACTIVE INGREDIENT*

NIGHTTIME
Sleep Aid

DIPHENHYDRAMINE HCl, 25 mg

NIGHTTIME SLEEP-AID

Non-Habit Forming

Not for Treating Cold or Flu

200 CAPLETS

OUR PHARMACISTS RECOMMEND

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA1217 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

QUALITY GUARANTEED

*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark VICKS® Zzz Quil™.

50844   ORG021567206

Topcare 44-672

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-672
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)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	44;672
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-672-06	200 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	07/24/2015

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(36800-672) , PACK(36800-672)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(36800-672)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(36800-672)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(36800-672)