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  5. Label Information: Allergy Antihistamine

FDA Label for Allergy Antihistamine

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Antihistamine Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. 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.

Otc - Active Ingredient



Active Ingredients

Diphenhydramine HCl 25 mg

Otc - Purpose



Antihistamine


Dosage & Administration



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 over: 1 to 2
caplets • Children 6 to under 12 years of age: 1
caplet • children under 6 years of age: do not use
this product in children under 6 years of age


Indications & Usage



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 due to the common cold: • runny nose
• sneezing


Warnings



Warnings: Do not use • to make a child sleepy• with any other product containing diphenhydramine, even oneused on skin Ask a doctor before use if you have: • abreathing problem such as emphysema or chronic bronchitis• glaucoma • trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are: takingsedatives or tranquilizers When using this product: • markeddrowsiness may occur • avoid alcoholic drinks • alcohol,sedatives, and tranquilizers may increase drowsiness • becareful when driving a motor vehicle or operating machinery• excitability may occur, especially in children.

Otc - Pregnancy Or Breast Feeding



If pregnant or
breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.


Inactive Ingredient



Inactive ingredients: carnauba wax,
colloidal silicon dioxide, croscarmellose sodium, DC red 27
aluminum lake, dibasic calcium phosphate dihydrate,
hydroxypropylmethyl cellulose, hypromellose, lactose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol (PEG) 400, polysorbate 80, silicon dioxide, titanium
dioxide


Package Label.Principal Display Panel



MM1


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