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Sleep Aid by Cardinal Health

Medically reviewed on Jan 18, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Cardinal Health
NDC Code: 70000-0142

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.

Leader 44-656

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 (1-800-222-1222) right away.

Directions
  • adults and children 12 years and over: 1 capsule (50 mg) at bedtime if needed, or as directed by a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

‚Äč1-800-426-9391

Principal Display Panel

LEADER™

NDC 70000-0142-1

Sleep Aid
Diphenhydramine HCl, 50 mg | Nighttime Sleep-Aid

Fall Asleep Fast
Safe, Non-habit Forming

32 LIQUID GELS

ACTUAL SIZE

COMPARE TO UNISOM® SLEEPGELS® active ingredient*

100% Money Back Guarantee

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

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

50844  ORG031565627

Product of China
Packaged and Quality Assured in the USA

CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com  1-800-200-6361
Assential to Care™ since 1979

©2016 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO, LEADER,
and the Leader LOGO are trademarks or registered
trademarks of Cardinal Health.

Leader 44-656

SLEEP AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0142
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
MINERAL OIL 
POLYETHYLENE GLYCOL, UNSPECIFIED 
WATER 
SORBITOL 
Product Characteristics
ColorBLUE (clear) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code656
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0142-11 BOTTLE in 1 CARTON
132 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33803/01/2015
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(70000-0142)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(70000-0142)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(70000-0142)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(70000-0142)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70000-0142)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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