CHEST CONGESTION RELIEF- guaifenesin liquid 
RUGBY LABORATORIES

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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Active ingredients

Guaifenesin 100 mg

Purpose

Expectorant

Uses

helps lossen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use if you ever had an allergic reaction to any of the indregients in this product

Ask a doctor before use if you have

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 (1-800-222-1222) right away.

Directions

 Adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours
 children under 12 years ask a doctor

Inactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, sucralose

Questions or comments? 1-800-645-2158

chestcongest

CHEST CONGESTION RELIEF 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1314
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium citrate (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1314-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2020
Labeler - RUGBY LABORATORIES (079246066)

Revised: 3/2022
Document Id: f78f166a-24ff-429a-b043-daa72a2be9f6
Set id: 51b088bc-b44f-44b9-a08e-133509a35a2c
Version: 3
Effective Time: 20220329
 
RUGBY LABORATORIES