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Publix Super Markets Inc

Publix Allergy Tablets Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

allergy Uses

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

Warnings

Do not use

  • •with any other product containing diphenhydramine, even one used on skin
  • •to make a child sleepy

Ask a doctor before use if you have

  • •glaucoma
  • •trouble urinating due to an enlarged prostate gland
  • •a breathing problem such as emphysema or chronic bronchitis

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
  • •excitability may occur, especially in children
  • •alcohol, sedatives and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery

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

1 or 2 tablets

children 6 to under 12 years of age

1 tablet

children 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

Other information

  • •each tablet contains: calcium 20 mg
  • •store at 20°-25°C

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments? 1-888-267-3037

Principal Display Panel

Allergytablets

DIPHENHYDRAMINE HCI 25 mg

ANTIHISTAMINE

For the temporary relief of:

itchy, watery eyes

runny nose

sneezing

itchy throat

ACTUAL SIZE

EASY TO SWALLOW

*Compare to Active Ingredient in Benadryl®

Allergy Ultratab®

allergy

Diphenhydramine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-479
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
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
STEARIC ACID
titanium dioxide
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE

Product Characteristics

Color Size Imprint Code Shape
PINK (dark) 10 mm L479 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 12 in 1 BLISTER PACK
3 100 in 1 BOTTLE
4 NDC:56062-479-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1998-05-07


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Be sure to consult your doctor before taking any medication!
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