ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE- dextromethorphan hbr, guaifenesin liquid

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:

Select Brand Dist.

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough suppressant Expectorant - 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 make coughs more productive

Authorization status:

OTC monograph final

Summary of Product characteristics

ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE-
DEXTROMETHORPHAN
HBR, GUAIFENESIN LIQUID
SELECT BRAND DIST.
_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 INGREDIENTS (IN EACH 5 ML)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
PURPOS ES
Cough suppressant
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 make
coughs more productive
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
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
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 THE REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center (1-800-222-1222)
immediately.
DIRECTIONS
do not exceed 6 doses in a 24-hour period
this adult product is not intended for use in children under 12 years
of age
use enclosed dosage cup
tsp = teaspoon, mL = milliliter
age
dose
adults and children 12 years and over 10 mL every 4 hours
children under 12 years
do not use
OTHER INFORMATION
store at room temperature
INACTIVE INGREDIENTS
acesulfame potassium, citric acid, flavors, glycerin, methy