FDA Label for Guaifenesin 200mg

View Indications, Usage & Precautions

Guaifenesin 200mg Product Label

The following document was submitted to the FDA by the labeler of this product Marlex 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 Ingredient (In Each Tablet)



Guaifenesin 200mg


Purpose



Expectorant

Guaifenesin 200 mg Tablets


Uses



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


Warnings



Ask a doctor before use if you have

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

Stop Use And Ask A Doctor If



cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

 


If Pregnant Or Breast- Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions:



  • Do not take more than 6 doses in any 24-hour period.
  • This product is not intended for use in children under 12 years of age
  • Adults & children 12 years and over: 1 to 2 tablets every 4 hours
  • Children under 12 years: do not use

Other Information:



  • Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients:



Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL


Principal Display Panel



NDC 10135-0681-01
Guaifenesin
200 mg
100 TABLETS


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