GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE - guaifenesin and dextromethorphan hydrobromide liquid

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:

LLC Federal Solutions

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose of Guaifenesin: Expectorant Purpose of Dextromethorphan HBr: Cough Suppressant Uses - temporarily relieves cough due to minor throat and bronchial irritation - helps loosen phlegm (mucus) - thin bronchial secretions to make coughs more productive Stop use and ask a doctor if - cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition - hypersensitive to any ingredients

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE - GUAIFENESIN AND
DEXTROMETHORPHAN HYDROBROMIDE LIQUID
LLC FEDERAL SOLUTIONS
_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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ACTIVE INGREDIENT:
Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))
ACTIVE INGREDIENT:
Dextromethorphan HBr 10 mg (in each 5 mL (teaspoon)(TSP))
PURPOSE OF GUAIFENESIN:
Expectorant
PURPOSE OF DEXTROMETHORPHAN HBR:
Cough Suppressant
USES
temporarily relieves cough due to minor throat and bronchial
irritation
helps loosen phlegm (mucus)
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
persistent cough or chronic cough such as occurs with smoking, asthma,
chronic bronchitis,
emphysema
cough accompanied by excessive phlegm (mucus)
STOP USE AND ASK A DOCTOR IF
cough lasts more than 7 days or occurs with fever, rash, or headaches
that lasts. This could be signs
of a serious condition
hypersensitive to any ingredients
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of overdose,
get medical help or contact a
Poison Control Center right away.
DIRECTIONS
take every 4 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
Adult and children 12 years and
over
2 teaspoonfuls
(TSP)
CHILDREN UNDER 12 YEARS
DO NOT USE
OTHER INFORMATION
Store at room temperature between 15°-30°C (59°-86°F)
Does not cause drowsiness
INACTIVE INGREDIENTS
citric acid, strawberry flavor, glycerin, menthol, methylparaben,
prop