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  5. Label Information: Childrens Pediaclear Pd

FDA Label for Childrens Pediaclear Pd

View Indications, Usage & Precautions

Table of Contents

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

Childrens Pediaclear Pd 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 2 Ml)



Triprolidine HCI 1.25 mg


Purpose



Antihistamine


Uses



■ temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

■ runny nose       ■ itching of the nose or throat

■ sneezing       ■ itchy, watery eyes


Warnings



Do not exceed recommended dosage.


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



■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect


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 dropper

■ do not use dropper for any other drug product

■ mL= milliliter

■ Professional Labeling: Take under guidance of health professionals.

children 6 to under 12 years of age:       2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

     

children 4 to under 6 years of age:       1.5 mL ever 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

           

children 2 to under 4 years of age:       1 mL ever 6 hours, not to exceed 4 doses in 24 hours

or as directed by a doctor.

infants 4 months to under 2 years of age: .5 mL every 6 hours, not to exceed 4 doses in 24 hours or as directed by a doctor.


Other Information



■ 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, sodium saccharin, sorbitol


Questions Or Comments?



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

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76015


Principal Display Panel



NDC 58809-651-50
Children’s
PediaClear
PD
Drops
1.69 fl oz (50 mL)


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