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Allergy

SuperValu (Equaline)

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Allergy 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
  • itching 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 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.

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

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

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.

Principal Display Panel

Compare to Benadryl® Allergy ultratabs® Active Ingredient*

Allergy

Antihistamine

For allergy relief:

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

Diphenhydramine HCl 25 mg

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy Ultratabs®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 55344 USA

PRODUCT OF USA

CONTACT US AT 1-877-932-7948, OR WWW.SUPERVALU-OUROWNBRANDS.COM

Product Label

Allergy
Diphenhydramine HCl 25mg

Allergy

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41163-690
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
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
polysorbate 80
POLYVINYL ALCOHOL
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:41163-690-24 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2010-07-22


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Be sure to consult your doctor before taking any medication!
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