DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE- dextromethorphan hydrobromide, guaifenesin, and phe

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), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Monarch PCM, LLC.

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 ○ nasal congestion due to a cold

Authorization status:

OTC monograph final

Summary of Product characteristics

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE
HYDROCHLORIDE- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND
PHENYLEPHRINE
HYDROCHLORIDE LIQUID
MONARCH PCM, LLC.
_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,AND PHENYLEPHRINE HCL
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
70154-112-08
8 fl. Oz. (240 mL)
ACTIVE INGREDIENTS (IN EACH 15 ML (TBSP))
Dextromethorphan HBr 18 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
PURPOS E
US ES
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
○ nasal congestion due to a cold
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
heart disease
high blood pressure
thyroid disease
diabetes
a cough that lasts or is chronic such as occurs with smoking, asthma,
or emphysema
a cough that occurs with too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
STOP USE AND ASK A DOCTOR IF:
■ nervousness, dizziness, or sleeplessness occurs
■ symptoms do not improve within 7 days, tend to recur, or
are accompanied by a fever, rash or persistent headache.
A persistent cough may be a sign of a serious condition.
■ new symptoms occur
IF PREGNANT OR BRE