Antihistamine Allergy description, usages, side effects, indications, overdosage, supplying and lots more!

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Antihistamine Allergy

H E B
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Antihistamine Allergy Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose

    • sneezing

    • itchy, watery eyes

    • itching of the nose or throat

  • temporarily relieves these symptoms due to the common cold:
    • runny nose

    • sneezing

Warnings

Do not use

  • to make a child sleepy
  • 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

  • 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

  • marked drowsiness may occur

  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children

If pregnant of 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. (1-800-222-1222)

Directions

  • take every 4 to 6 hours

  • do not take more than 6 doses in 24 hours 

 adults and children 12 years of age and over  take 1 to 2 tablets
 children 6 to under 12 years of age  take 1 tablet
 children under 6 years of age  do not use this product in children under 6

Antihistamine Allergy 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 Ultratab®

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide

* contains one or more of these ingredients

Questions or Comments?

Call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Antihistamine Allergy

For Allergy Relief

Diphenhydramine Hydrochloride 25 mg

  • sneezing
  • itchy, watery eyes
  • runny nose
  • itchy throat

Compare to the Active Ingredient in Benadryl® Allergy Ultratab® **

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

Product Label

Antihistamine Allergy

Diphenhydramine HCl 25 mg
 

Antihistamine Allergy

Diphenhydramine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37808-690
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
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
EGG PHOSPHOLIPIDS
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
polysorbate 80
POLYVINYL ALCOHOL
water
talc
titanium dioxide
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
PINK 12 mm T;61;V;25;S4 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:37808-690-48 4 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2011-12-01


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