GUAIFENESIN SYRUP AND DEXTROMETHORPHAN syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

Natco Pharma USA LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Non-Narcotic - Alcohol Free • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Product summary:

HOW SUPPLIED:  Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms: NDC 69339-149-05 (1) unit dose cup 5mL NDC 69339-149-19 100 (10x10) unit dose cups 5mL Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 69339-150-01 (1) unit dose cup 10mL NDC 69339-150-19 100 (10x10) unit dose cups 10mL

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN SYRUP AND DEXTROMETHORPHAN- GUAIFENESIN SYRUP AND
DEXTROMETHORPHAN SYRUP
NATCO PHARMA USA LLC
----------
GUAIFENESIN SYRUP AND DEXTROMETHORPHAN
_Non-Narcotic - Alcohol Free_
DRUG FACTS
ACTIVE INGREDIENT (IN EACH 5 ML CUP) PURPOSE
Guaifenesin, USP 100mg
..............................................................................................................................
Expectorant
Dextromethorphan HBr, USP 10mg
......................................................................................................
Cough Suppressant
ACTIVE INGREDIENT (IN EACH 10 ML CUP) PURPOSE
Guaifenesin, USP 200mg
..............................................................................................................................
Expectorant
Dextromethorphan HBr, USP 20mg
.......................................................................................................Cough
Suppressant
INACTIVE INGREDIENTS
_Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin,
high fructose corn_
_syrup, menthol, purified water, saccharin sodium, sodium benzoate._
USES
• helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more
productive.
• temporarily relieves cough due to minor throat and bronchial
irritation as may occur
with a cold.
WARNINGS
DO NOT USE if you are now taking a prescription monoamine oxidase
inhibitor (MAOI) or
for two weeks after stopping the MAOI drug.
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
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking any other drug
STOP USE AND ASK A DOCTOR IF
• your cough lasts more than 7 days, comes back, or is accompanied
by fever, rash, or
persistant headache.
• you are hypersensitive to any of the ingredients
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 Con