FDA Label for Anti Allergy

View Indications, Usage & Precautions

Anti Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Advance Pharmaceutical 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)

Chlorpheniramine Maleate 4 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms of hay fever or other upper respiratory allergies :

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

Warnings



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

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives & tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating a machine
    • excitability 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[/S]



Adults & children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 yearstake ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours
children under 6 yearsdo not use

Other Information



  • each tablet contains: calcium 40 mg
  • store between 15°-30°C (59°-86°F)
  • protect from moisture

Inactive Ingredients



croscarmellose sodium, D&C yellow #10 (al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch


Questions Or Comments



Call 1-800-645-2158, 8.30 am – 4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED


Package Label.Principal Display Panel



Chlorpheniramine Maleate 4 mg
Antihistamine

17714-016-01  100 Tablets


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