GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE tablet

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:

Yichang Humanwell Pharmaceutical Co. Ltd.

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 20 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

■Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■Helps make coughs more productive.

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- GUAIFENESIN AND
DEXTROMETHORPHAN HYDROBROMIDE TABLET
YICHANG HUMANWELL PHARMACEUTICAL CO. LTD.
_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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GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLETS, 400 MG/20 MG
_ACTIVE INGREDIENT (per tablet)_
_PURPOSE_
Dextromethorphan Hydrobromide 20mg
Cough Suppressant
Guaifenesin 400mg
Expectorant
_USES_
■Temporarily relieves cough due to minor throat and bronchial
irritation as may occur with a common
cold
■Helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of
bothersome mucus
■Helps 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 a
MAOI, ask a doctor or
pharmacist before using 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 that is accompanied by excessive phlegm (mucus)
STOP USE AND ASK A DOCTOR IF
■ symptoms are accompanied by fever, rash, or persistent headache
■ cough persists for more than 1 week or tends to recur.
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 immediately.
_DIRECTIONS_
■ ADULTS AND CHILDREN 12 YEARS AND OVER: take 1 tablet every 4 hours
as needed
■ CHILDREN 6 TO UNDER 12 YEARS: take 1/2 tablet every 4 hours as
needed
■ CHILDREN UNDER 6 YEARS: consult a doctor
DO NOT EXCEED 6 DOSES IN A 24 HOUR PERIOD OR AS DIRECTED BY A DOCTOR
_OTHER