FDA Label for Little Remedies Little Colds Mucus Relief Expectorant Melt Aways

View Indications, Usage & Precautions

Little Remedies Little Colds Mucus Relief Expectorant 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



Guaifenesin 100 mg (in each packet)


Purpose



Expectorant


Use



Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


Ask A Doctor Before Use If You Have:



  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If:



Cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.


When Using This Product:



Do not exceed recommended dosage.

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
  • Do not take more than 6 doses in any 24-hour period
  • AgeDose
    Under 4 yearsDo not use
    4 – under 6 years1 packet every 4 hours
    6 to under 12 years 1 – 2 packets every 4 hours
    12 years and over 2 – 4 packets every 4 hours

Other Information



  • Store at 59–77°F (15–25°C).
  • Tamper Evident: Do not use if package has been disturbed or opened.
  • Check expiration date before using.

Inactive Ingredients



cellulose, cocoa butter, crospovidone, flavor, glucose, hydrogenated vegetable oil, hydroxypropyl methylcellulose, mannitol, methacrylic acid, polyethylene glycol, polysorbate 80, povidone, silicon dioxide, sodium lauryl sulfate, starch, sucralose, sucrose, talc, triethyl citrate


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

LC13101


Principal Display Panel



MEDICATED FOR KIDS 2+

LITTLE

Colds® 

By Little

Remedies

NEW!

MUCUS

RELIEF

Melt Aways

Guaifenesin Expectorant

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