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Leader SleepTime by Cardinal Health

Medically reviewed on Mar 19, 2018

Dosage form: solution
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: Cardinal Health
NDC Code: 49781-048

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.

Cardinal Health SleepTime Drug Facts

Active ingredient (in each 30 mL dose cup)

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
with other Nighttime products

Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to an 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
drowsiness will occur
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 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
use dose cup
 
adults & children 12 yrs & over
 
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 cup contains: sodium 20 mg
store at 20-25°C (68-77°F)
protect from light. Does not meet USP <671>.

Inactive Ingredients

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Vicks® ZzzQuil® active ingredient

SleepTime

Nighttime Sleep-Aid

Diphenhydramine HCl 50 mg per 30 mL

Not for treating Cold or Flu

See Warnings

Berry Flavor

Non-Habit Forming

ALCOHOL 10%

6 FL OZ (177 mL)

LEADER SLEEPTIME 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-048
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
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM CITRATE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-048-06177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33810/11/2013
Labeler - Cardinal Health (097537435)

 
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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