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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. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson. 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 of hay fever or other upper respiratory allergies:

  • runny nose
  • itching of the nose or throat
  • sneezing
  • itchy, watery eyes

    temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Warnings



Do not use

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

    Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a 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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • take every 4 to 6 hours
  • do not take more than 6 tablets in 24 hours
    Age (Yr) Dose (tablets)
    Adults and children 12 years of age and overTake 1 to 2 tablets
    Children 6 to under 12 years of ageTake 1 tablet
    Children under 6 years of agedo not use

Other Information



  • store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
  • protect from light and moisture
  • metal content: each tablet contains: Calcium 23mg, Magnesium: 0.2 mg, sodium 0.5 mg

Inactive Ingredients



Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, Lecithin,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, Polyvinyl Alcohol, polysorbate, Povidone, Purified water, starch, sodium benozoate, talc,Titanium Dioxide


Questions Or Comments



Call 1-855-314-1850

READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION


Package Label.Principal Display Panel



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NDC 70677-0009-1


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