ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin capsule, liquid filled

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:

Haleon US Holdings LLC

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 10 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 cold - helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Authorization status:

OTC monograph final

Summary of Product characteristics

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM-
DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN CAPSULE, LIQUID FILLED
HALEON US HOLDINGS LLC
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_DRUG FACTS_
ACTIVE INGREDIENTS (IN EACH LIQUID-FILLED CAPSULE)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 200 mg
_PURPOSES_
Cough suppressant
Expectorant
_USES_
•
•
_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
•
•
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_
temporarily relieves cough due to minor throat and bronchial
irritation as may occur
with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain
bronchial tubes
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
•
•
AGE
DOSE
adults and children 12 years and over
2 capsules every 4 hours
children under 12 years
do not use
_OTHER INFORMATION_
•
•
_INACTIVE INGREDIENTS_
FD&C Red No. 40, gelatin, glycerin, light mineral oil, pharmaceutical
ink, polyethylene
glycol, povidone, propylene glycol, purified water, sorbitol sorbitan
solution
_QUESTIONS OR COMMENTS?_
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Made in Canada
For most recent product information, visit www.robitussin.com
Distributed by: Pfizer, Madison, NJ 07940 USA
PRINCIPAL DISPLAY PANEL
ADULT
ROBITUSSIN
MAXIMUM
STRENGTH
COUGH+CHEST
CONGESTIO