MUCUS RELIEF DM dextromethorphan hbr and guiafenesin tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

NASH-FINCH COMPANY

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 20 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCUS RELIEF DM- DEXTROMETHORPHAN HBR AND GUIAFENESIN TABLET, FILM
COATED
NASH-FINCH COMPANY
_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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OUR FAMILY 44-533 DELISTED
ACTIVE INGREDIENT(S)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
PURPOS E
Cough suppressant
Expectorant
US E(S )
temporarily relieves cough due to minor throat and bronchial
irritation associated with the common
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 accompanied by too much phlegm (mucus)
persistent or chronic cough 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 occurs with 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 REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
take with a full glass of water
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: 1 tablet every 4 hours.
Do not take more than 6
tablets in 24 hours.
CHILDREN UNDER 12 YEARS: do not use
OTHER INFORMATION
store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
INACTIVE INGREDIENTS
D&C yellow #10 aluminum lake, hypromellose, magnesium stearate,
maltodextrin, microcrystalline
cellulose, polyethylene glycol