DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN syrup

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:

OPMX Chula Vista

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant Relieves: • Chest congestion / Mucus • Cough - temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold - helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN-
DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SYRUP
OPMX CHULA VISTA
_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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DEXTROMETHORPHAN HBR
GUAIFENESIN
ACTIVE INGREDIENT (IN EACH 5 ML) PURPOSE
Dextromethorphan HBr USP 10 mg............. Cough suppressant
Guaifenesin, USP 100 mg............................... Expectorant
Relieves:
• Chest congestion / Mucus
• Cough
USES
temporarily relieves cough due to minor throat and bronchial
irritation as may occur
with a cold
helps to loosen phlegm (mucus) and thin bronchial secretions to drain
bronchial
tubes
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
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 REACH OF CHILDREN. In case of overdose, get medical help
or contact a
Poison Control Center right away.
DIRECTIONS
take evey 4 hours
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
AGE
DOSE
Adults and children 12 years and over
2 teaspoonful (10 mL)
Children 6 to under 12 years
1 teaspoonful (5 mL)
Children under 6 years
Ask a doctor
OTHER INFORMATION
Store at 20°-25°C (68° -77°F).
Do not refrigerate.
Retai