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  5. Label Information: Allergy

FDA Label for Allergy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL

Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


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

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 (1-800-222-1222).


Directions



  • •take every 4 to 6 hours, or as directed by a doctor
  • •do not take more than 6 doses in 24 hours

    • adults and children 12 years and over

    1 to 2 tablets

    children 6 to under 12 years

    1 tablet

    children under 6 years

    do not use


Other Information



  • •each tablet contains: calcium 20 mg
  • •store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.

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


Principal Display Panel



Allergy tablets

DIPHENHYDRAMINE HCl 25 mg

ANTIHISTAMINE

For the temporary relief of:

itchy, watery eyes

runny nose

sneezing

itchy throat

ACTUAL SIZE

100 TABLETS

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


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