GADAVYT COUGH DM- dextromethorphan hydrobromide, guaifenesin liquid

Gadavyt Cough by

Drug Labeling and Warnings

Gadavyt Cough by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr                                      Cough Suppressant

Guaifenesin 100mg                                          Expectorant

PURPOSE

USES

• temporarily quiets cough associated with the common cold or inhaled irritants
  

• Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  

WARNINGS

Warnings
Ask a doctor before use if

• you have cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
• cough occurs with too much phlegm (mucus)
  

DO NOT USE

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

• cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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 INGREDIENT

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

QUESTIONS

GADAL Laboratories, Inc.

Miami, Fl 33186

www.gadallaboratories.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GADAVYT COUGH  DM
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-557
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-557-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2012

Labeler - Gadal Laboratories Inc (841305639)