sleep time description, usages, side effects, indications, overdosage, supplying and lots more!

sleep time

HyVee Inc

  • 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
Hy-Vee, Inc. Sleep Time Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Diphenhydramine HCl 25 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
adults & children 12 yrs & overOne dose = TWO 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor
 
 

Other information

  • •avoid excessive heat above 40°C (104°F) and high humidity
  • •protect from light

Inactive ingredients

edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Vicks® ZzzQuil® Nighttime Sleep-Aid active ingredient

Sleep Time

Night Time Sleep-Aid

Diphenhydramine HCl 25 mg

Non-Habit Forming

Not for Treating Cold or Flu

See Warnings

12 SOFTGELS

sleep time

Diphenhydramine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42507-052
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
water

Product Characteristics

Color Size Imprint Code Shape
PURPLE 15 mm 052 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 BLISTER PACK
2 2 in 1 BLISTER PACK
3 NDC:42507-052-67 24 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2014-02-01


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