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  5. Label Information: Allergy

FDA Label for Allergy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS

Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


Uses



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


Warnings



Do not usewith any other products containing diphenhydramine, including one applied topically


Ask A Doctor If You Have



a breathing problem such as emphysema or chronic bronchitis, glaucoma or 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 beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga motor vehicle or operating machinery
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 accidental overdose, contact a doctor or Poison Control Center immediately


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 older: 25 mg to 50 mg (1 to 2 caplets)
Children 6 to under 12 years of age (See ** symbol below): 12.5 mg** to 25 mg (1 caplet)
Children under 6 years of age: Consult a doctor
** A 12.5 mg dosage strength is not available in this package. (Do not attempt to break caplet)


Inactive Ingredients



croscarmellose sodium, D.&C. Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide


* Please review the disclaimer below.