GADAVYT COUGH DM- dextromethorphan hydrobromide, guaifenesin liquid 
Gadal Laboratories Inc

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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Drug Facts

Active Ingredient (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr                                      Cough Suppressant

Guaifenesin 100mg                                          Expectorant

USES

Warnings
Ask a doctor before use if

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

Stop use and ask a doctor if

Keep out of the reach of children. In case of
overdose, get medical help or contact a Poison Control Center
right away.

If pregnant or breast-feeding, ask a health professional
before use.

Directions

do not take more than 6 doses in any 24 hour period

adults and children 12 years and over
2 TSP every 4 hours or as directed by doctor
children under 12 years
do not use

Other information
store at room temperature  15 - 30 degrees C (59 - 86 degrees F)
TAMPER-EVIDENT: Do not use if seal under cap is torn,
broken or missing.

Inactive Ingredients
Citric acid, methylparaben, propylparaben,glycerin, sucralose,
sodium citrate, FD and C Red No. 40, menthol, natrosol, cherry flavor,
purified water

GADAL Laboratories, Inc.

Miami, Fl 33186

www.gadallaboratories.com

coughdmlabel

GADAVYT COUGH  DM
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-557
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-557-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2012
Labeler - Gadal Laboratories Inc (841305639)

Revised: 12/2012
Document Id: 77ed1487-5de6-47c6-b4e1-abaf25512649
Set id: 1906ab0e-42dc-4619-87a3-d7a30f432a95
Version: 1
Effective Time: 20121217
 
Gadal Laboratories Inc