COUNTERACT COUGH- dextromethorphan hbr. and guaifenesin syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Melaleuca, Inc.

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Dextromethorphan HBr, USP 10 mg..........Cough Suppressant Guaifenesin, USP 100 mg............................Expectorant Uses - temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold - helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Authorization status:

OTC monograph final

Summary of Product characteristics

COUNTERACT COUGH- DEXTROMETHORPHAN HBR. AND GUAIFENESIN SYRUP
MELALEUCA, 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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COUNTERACT COUGH CONTENT OF LABEL
ACTIVE INGREDIENTS (IN EACH 5 ML TSP)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
PURPOSE
Dextromethorphan HBr, USP 10 mg..........Cough Suppressant
Guaifenesin, USP 100 mg............................Expectorant
US ES
temporarily relieves cough due to minor throat and bronchial
irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain
bronchial tubes
WARNINGS
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 your prescription drug
contains an MAOI, ask a
doctor or pharmacist before taking this product.
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 for more than 7 days, comes
back, or occurs with fever, rash
or persistent headache. A persistent cough may be a sign 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
do not take more than 6 doses in any 24-hour period
this adult product is not intended for use in children under 12 years
of age
age
dose
adults and children
12 years and over
2 tsp every
4 hours
children under 12
years
do not use
OTHER INFORMATION
store at 20°-25°C (68°-77°F)
INACTIVE INGREDIENTS anhydrous citric acid, FD and C red no. 40,
flavors, glycerin, high fructose corn
syrup, propy