ROBITUSSIN PEAK COLD MULTI-SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

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:

Haleon US Holdings LLC

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough suppressant Expectorant Nasal decongestant - helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes - temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation - nasal congestion - cough due to minor throat and bronchial irritation

Authorization status:

OTC monograph final

Summary of Product characteristics

ROBITUSSIN PEAK COLD MULTI-SYMPTOM COLD- DEXTROMETHORPHAN
HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE LIQUID
HALEON US HOLDINGS LLC
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_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH 10 ML)_
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Phenylephrine HCl, USP 10 mg
_PURPOSES_
Cough suppressant
Expectorant
Nasal decongestant
_USES_
helps loosen phlegm (mucus) and thin bronchial secretions to drain
bronchial tubes
temporarily relieves these symptoms occurring with a cold:
nasal congestion
cough due to minor throat and bronchial irritation
_WARNINGS_
DO NOT USEif 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
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma,
chronic
bronchitis or emphysema
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU AREtaking any other oral
nasal
decongestant or stimulant.
WHEN USING THIS PRODUCT DO NOT USE MORE THAN DIRECTED.
STOP USE AND ASK A DOCTOR IF
you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
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_
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
ml = milliliter
this adult product is not intended for use in children under 12 y