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  5. Label Information: Little Colds Sore Throat Relief Melt Aways

FDA Label for Little Colds Sore Throat Relief Melt Aways

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. WHEN USING THIS PRODUCT:
    6. STOP USE AND ASK A DENTIST OR DOCTOR IF:
    7. IF PREGNANT OR BREAST-FEEDING
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS
    13. PRINCIPAL DISPLAY PANEL

Little Colds Sore Throat Relief Melt Aways Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products 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



Benzocaine 6 mg (in each packet)


Purpose



Oral Anesthetic/Analgesic


Use



For the temporary relief of occasional minor irritation, pain, sore throat, and sore mouth.


Warnings



Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under (3) years of age unless directed by a doctor.


When Using This Product:



do not exceed recommended dosage.


Stop Use And Ask A Dentist Or Doctor If:



sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; swelling, rash or fever develops.  


If Pregnant Or Breast-Feeding



ask a health care professional before use.  


Keep Out Of Reach Of Children.



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


Directions



  • Empty entire contents of packet onto tongue, allow to dissolve, then swallow
  • For best taste, do not chew granules
    • AgeDose
    under 3 yearsConsult a doctor
    3 to under 6 years1 packet every 2 hours as needed
    6 years and over1 – 2 packets every 2 hours as needed

Other Information



  • Store at 59–77°F (15–25°C).
  • Tamper Evident: Do not use if foil packets are broken.
  • Check expiration date before using.

Inactive Ingredients



cocoa butter, crospovidone, flavor, glucose, hypromellose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucralose, sucrose, talc


Questions



For further information you may contact us at: 1-800-7-LITTLE, or visit us at www.LittleRemedies.com.

©2009 Dist. by Medtech Products Inc.

Irvington, NY 10533

A Prestige Brands Company

LC14101


Principal Display Panel



MEDICATED FOR KIDS 3+

LITTLE

Colds® 

By Little

Remedies

NEW!

SORE

THROAT

RELIEF

Melt Aways

Benzocaine – Oral Anesthetic / Analgesic

* Please review the disclaimer below.