Leader SleepTime description, usages, side effects, indications, overdosage, supplying and lots more!

Leader SleepTime

Cardinal Health

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Cardinal Health SleepTime Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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 & overOne dose = 30 mL at bed time if needed or as directed by a doctor
 
 

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%

6FL OZ (177 mL)

Leader SleepTime

Diphenhydramine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49781-048
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49781-048-06 177 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2013-10-11


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Be sure to consult your doctor before taking any medication!
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