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LEADER Nighttime Sleep-Aid by CARDINAL HEALTH

Medically reviewed on March 10, 2017

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: CARDINAL HEALTH
NDC Code: 70000-0174

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.

Sleep Aid Diphenhydramine HCl 50 mg Nighttime Sleep Aid Berry Flavor 6 FL OZ 177mL

Drug Facts

Active ingredient
(in each 30 mL)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses
for the 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
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
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.1-800-222-1222

Directions
take only one dose per day (24 hours) – see Overdose warning
Measure with dosing cup provided.

adults & children 12 yrs & over

One Dose = 30 mL at bed time if needed or as directed by a doctor

Children under 12 yrs

Do not use

Other information
each 30 mL dose contains: sodium 23 mg
store at room temperature
protect from light. Does not meet USP <671>

Inactive ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0174-2

Sleep Aid

Diphenhydramine HCl , 50 mg

Nighttime Sleep-Aid

COMPARE TO ZZZQUILNIGHTTIME SLEEP-AID active ingredient*

100% Money Back Guarantee

Berry Flavor

Naturally & Artificially Flavored

 
Non-Habit forming
 
Alcohol- Free
 
Not for Treating Cold or Flu
 
See Warnings

6 FL OZ (177 mL)

©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.

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

*This product is not manufactured or distributed by Procter & Gamble, the owner of the registered trademark ZzzQuil™ Nighttime Sleep-Aid.

LEADER NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0174
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
POTASSIUM CITRATE 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0174-2177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33803/13/2017
Labeler - CARDINAL HEALTH (097537435)

 
CARDINAL HEALTH

← See all LEADER Nighttime Sleep-Aid brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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