GUAIFENESIN- guaifenesin liquid 
Method Pharmaceuticals, LLC

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.

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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

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

Drug Facts (continued)

Other information

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)

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58657-509-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/09/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/09/2016
Labeler - Method Pharmaceuticals, LLC (060216698)
Establishment
NameAddressID/FEIBusiness Operations
Monarch PCM, LLC080000294manufacture(58657-509)

Revised: 12/2021
Document Id: d45f559d-5412-8f88-e053-2a95a90ac45a
Set id: 312ce620-4841-7488-e054-00144ff88e88
Version: 4
Effective Time: 20211230
 
Method Pharmaceuticals, LLC