MUCINEX DM MAXIMUM STRENGTH- guaifenesin and dextromethorphan hydrobromide tablet, extended release

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:

RB Health (US) LLC

INN (International Name):

Guaifenesin

Composition:

Guaifenesin 1200 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 - 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 MAXIMUM STRENGTH- GUAIFENESIN AND DEXTROMETHORPHAN
HYDROBROMIDE TABLET, EXTENDED RELEASE
RB HEALTH (US) LLC
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MUCINEX®DM
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_EXTENDED-RELEASE BI-LAYER_
_TABLET)_
_PURPOSES_
Dextromethorphan HBr 60 mg
Cough suppressant
Guaifenesin 1200 mg
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 tablet every 12 hours; not
more than 2
tablets in 24 hours
children under 12 years of age: do not use
OTHER INFORMATION
store at 20-25°C (68-77°F)
INACTIVE INGREDIENTS
carbomer homopolymer type B; D&C yellow no. 10 aluminum lake;
hyp