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

topcare sleep aid

Topco Associates LLC

  • 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
Topco Associates LLC. Sleep Aid Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness lasts 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Other information

  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

collodial silicon dioxide, crospovidone, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

FALL ASLEEP FAST! • NON HABIT-FORMING

Nighttime

Sleep Aid

DIPHENHYDRAMINE HCl

Contains no pain reliever

actual size

COMPARE TO SIMPLY SLEEP™ active ingredient

Principal Display Panel
Sleep Aid Carton Image 1 Sleep Aid Carton Image 2

topcare sleep aid

Diphenhydramine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-151
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
SILICON DIOXIDE
CROSPOVIDONE
cellulose, microcrystalline
POLYVINYL ALCOHOL
povidone
STEARIC ACID
talc
titanium dioxide
POLYETHYLENE GLYCOLS

Product Characteristics

Color Size Imprint Code Shape
WHITE 16 mm L151 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:36800-151-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2010-11-03


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Be sure to consult your doctor before taking any medication!
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