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Allergy

Greenbrier International, Inc.

Assured 44-329


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Allergy Uses

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

    • runny nose

    • itchy, watery eyes

    • sneezing

    • itching of the nose or throat

  • temporarily relieves these symptoms due to the common cold:

    • runny nose

    • sneezing

Do not use

  • to make a child sleepy

  • ith 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

  • marked drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating machinery

  • may occur, especially in children

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

  • do not take more than 6 doses in 24 hours

adults and children 12 years of age
and over

1 to 2 tablets 
 children 6 to under 12 years of age  1 tablet   
 children under 6 years of age  do not use

Allergy Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT IN BENADRYL® ULTRATAB®*

Allergy
For the temporary relief of:
Itchy Throat
Runny Nose
Itchy, Watery Eyes
Sneezing

36 Tablets

Antihistamine • Diphenhydramine HCl 25 mg

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
50844    REV0512B32907

Distributed by:
Greenbrier International, Inc.
Chesapeake, VA 23320

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Allergy
Assured 44-329

Allergy

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0329
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
cellulose, microcrystalline
D&C RED NO. 27
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
SILICON DIOXIDE
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PINK 11 mm 44;329 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 36 in 1 BOTTLE, PLASTIC
2 NDC:33992-0329-7 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1990-03-02


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Be sure to consult your doctor before taking any medication!
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