Diphenhydramine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Diphenhydramine Hydrochloride

AAA Pharmaceutical, Inc.

Diphenhydramine HCl Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

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

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

Directions

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

Diphenhydramine Hydrochloride Other information

  • each caplet contains: calcium 45 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

RESTORE u

NDC 57344-091-01

COMPARE TO THE
ACTIVE INGREDIENT IN
SIMPLY SLEEP®

Fall Asleep Fast,
Wake Up Refreshed;
Safe and Non-Habit
Forming

Rest Simply
NIGHTTIME SLEEP-AID

Diphenhydramine HCl
Contains No Pain Reliever

24 CAPLETS

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-091
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
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 11 mm 25;052 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 12 in 1 BLISTER PACK
3 100 in 1 BOTTLE, PLASTIC
4 200 in 1 BOTTLE, PLASTIC
5 NDC:57344-091-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2012-12-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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