Sleep Aid description, usages, side effects, indications, overdosage, supplying and lots more!

Sleep Aid

Kareway Product, 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
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged 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.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and older

take 2 tablets at bedtime if needed or as directed by your doctor.

Other information

  • each tablet contains:calcium 0.2mg
  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

FDC blue #1, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch, dicalcium phosphate, stearic acid, silcon dioxide, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

Package label

Enter section text herePackage label

Sleep Aid

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67510-0160
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
MICROCRYSTALLINE WAX
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
STEARIC ACID
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
titanium dioxide
ETHANETHIOL

Product Characteristics

Color Size Imprint Code Shape
blue 9 mm RM ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 NDC:67510-0160-0 2 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2011-08-18


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Be sure to consult your doctor before taking any medication!
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