Sunmark z-sleep description, usages, side effects, indications, overdosage, supplying and lots more!

Sunmark z-sleep

McKesson

  • 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
McKesson z-Sleep™ 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® ACTIVE INGREDIENT

z-sleep™

Nighttime Sleep-Aid

not for treating cold or flu

see warnings

Diphenhydramine HCl 25 mg

NON-HABIT FORMING

GLUTEN FREE

12 SOFTGELS

Sunmark z-sleep

Diphenhydramine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-413
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 NDC:49348-413-02 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2014-01-31


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Be sure to consult your doctor before taking any medication!
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