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

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Diphenhydramine Hydrochloride

Avema Pharma Solutions

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Diphenhydramine Hydrochloride Uses

  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes

Warnings

Do not use 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
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

  • excitability may occur especially in children
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when operating machinery or driving a motor vehicle

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

  • take every 4 to 6 hours, not more than 6 doses in 24 hours
   adults and children 12 years of age and over    take 1 or 2 tablets
   children 6 to under 12 years of age    take 1 tablet
   children under 6 years of age    consult a doctor
   children under 4 years of age   do not use

Diphenhydramine Hydrochloride Other information

  • each tablet contains: calcium 25 mg/tablet
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light and moisture
  • *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy Ultratabs.

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80 and titanium dioxide. May also contain: polyvinyl alcohol and talc.

Package/Label Principal Display Panel

Diphenhydramine Hydrochloride

NDC 63548-6373-*1

*Compare to the active ingredient in Benadryl® Allergy Ultratabs®

Antihistamine

Allergy Tablets

Diphenhydramine Hydrochloride 25 mg

For Allergy Relief

Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat

24 Tablets


THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63548-3482
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
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
D&C RED NO. 27
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
POLYVINYL ALCOHOL
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PINK 4 mm V25 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63548-3482-1 24 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-01-02


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