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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to 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 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 tablets at bedtime if needed, or as directed by a doctor

Diphenhydramine Hydrochloride Other information

  • each tablet contains: calcium 85 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, magnesium stearate, microcrystalline cellulose

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

PRINCIPAL DISPLAY PANEL - 16 Tablet Blister Pack Carton

RESTORE u

NDC 57344-019-01

COMPARE TO THE ACTIVE
INGREDIENT IN SOMINEX®

Get To Sleep Safely,
Wake Up Refreshed

Somnitabs
NIGHTTIME SLEEP-AID

Diphenhydramine HCl

16 TABLETS - 25 mg each

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

DIPHENHYDRAMINE HYDROCHLORIDE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-019
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
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm 93XF;57344 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 8 in 1 BLISTER PACK
4 NDC:57344-019-03 9 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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