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Guaifenesin by Method Pharmaceuticals, LLC

Medically reviewed on December 21, 2016

Dosage form: liquid
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Method Pharmaceuticals, LLC
NDC Code: 58657-509

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Guaifenesin

NDC 58657-509-16

Guaifenesin

Liquid USP

100 mg/5 Ml

Expectorant

Sugar Free • Alcohol Free

Cherry Flavor

Loosens and Relieves Chest Congestion

16 fl. oz. (473 mL)

Drug Facts

Active ingredient (in each 5 mL)

Guaifenesin 100 mg

Purpose

Expectorant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings

Ask a doctor before use if you have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 
    age dose adults and children 2 to 4 teaspoonfuls 
    12 years and over every 4 hours 
    children 6 years to 1 to 2 teaspoonfuls 
    under 12 years every 4 hours 
    children 2 years to ½ to 1 teaspoonful 
    under 6 years every 4 hours 
    children under 2 years ask a doctor

Drug Facts (continued)

Other information
  • store at 20°-25°C (68°-77°F)
  • packaged with tamper evident seal under cap

Inactive ingredients

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution

Questions or Comments

1-877-250-3427

Manufactured For:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118 Rev. 09/16

PRINCIPAL DISPLAY PANEL

NDC 58657- 509- 16
Guaifenesin
Liquid USP
100 mg/ 5 mL
Expectorant
16 fl. oz. (473 mL)

GUAIFENESIN 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-509
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58657-509-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/09/2016
Labeler - Method Pharmaceuticals, LLC (060216698)

 
Method Pharmaceuticals, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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