MUCINEX DM- dextromethorphan hydrobromide, guaifenesin tablet, extended release

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:

Navajo Manufacturing Company Inc.

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 30 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive - temporarily relieves: - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep

Authorization status:

New Drug Application

Summary of Product characteristics

MUCINEX DM- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN TABLET,
EXTENDED RELEASE
NAVAJO MANUFACTURING COMPANY INC.
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MUCINEX DM
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH EXTENDED-RELEASE BI-LAYER TABLET)_
Dextromethorphan HBr 30 mg
Guaifenesin 600 mg
_PURPOSES_
Cough suppressant
Expectorant
_USES_
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and make coughs more productive
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with
the common
cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you get to sleep
_WARNINGS_
DO NOT USE
for children under 12 years of age
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
persistent or chronic cough such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)
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 occurs with fever, rash,
or persistent
headache. These could be signs of a serious illness.
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 crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years and older: 1 or 2 tablets every 12 hours;
not more than
4 tablets in 24 hours
children under 12 years of age: do not use
_OTHER INFORMATION_
tamper evident: do not use if carton is damaged or if pouch is broken
or torn
store at 20-25°C (68-77°F)
_IN