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  5. Label Information: Childrens Pediaclear 8

FDA Label for Childrens Pediaclear 8

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    5. ASK A DOCTOR BEFORE USE IF THE CHILD IS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Childrens Pediaclear 8 Product Label

The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, 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 Ingredients



 (in each 15 mL)

Pyrilamine Maleate 12.5 mg


Purpose



Antihistamine


Uses



■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.


Ask A Doctor Before Use If The Child Has



■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma


Ask A Doctor Before Use If The Child Is



taking sedatives or tranquilizers


When Using This Product



■ marked drowsiness may occur

■ sedatives and tranquilizers may increase drowsiness

■ excitability may occur, especially in children


Stop Use And Ask A Doctor If



new symptoms occur


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



■ use only with enclosed dose cup and keep with product

■ mL= milliliter

■ professional labeling: for use under guidance of health professional only children 6 to under 12 years of age: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours. children 2 to under 6 years of age:15 mL (1 dose cup) every 6 to 8 hours, not to exceed 4 doses in 24 hours.


Other Information



■ each 15 mL contains: Sodium 6 mg

■ read all product information before using

■ store at room temperature 20-30°C (68-86°F)


Inactive Ingredients



citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose


Questions Or Comments?



Call 1-888-535-0305 9 a.m. - 5 p.m. CST.


Principal Display Panel



NDC 58809-770-08
Children’s
PediaClear
8 Eight
8 fl oz (237 mL)


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