DELSYM (DEXTROMETHORPHAN)- dextromethorphan suspension, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

RB Health (US) LLC

INN (International Name):

DEXTROMETHORPHAN

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough suppressant temporarily relieves - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the impulse to cough to help you get to sleep

Authorization status:

New Drug Application

Summary of Product characteristics

DELSYM (DEXTROMETHORPHAN)- DEXTROMETHORPHAN SUSPENSION, EXTENDED
RELEASE
RB HEALTH (US) LLC
----------
DELSYM
EXTENDED-RELEASE SUSPENSION
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan
hydrobromide
PURPOSE
Cough suppressant
USES
temporarily relieves
cough due to minor throat and bronchial irritation as may occur with
the common
cold or inhaled irritants
the impulse to cough to help you get to sleep
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
chronic cough that lasts such as occurs with smoking, asthma, or
emphysema
cough that occurs with too much phlegm (mucus)
STOP USE AND ASK A DOCTOR IF cough lasts more than 7 days, comes back,
or occurs
with fever, rash, or headache that lasts. 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
SHAKE BOTTLE WELL BEFORE USE
measure only with dosing cup provided
®
do not use dosing cup with other products
dose as follows or as directed by a doctor
adults and children 12 years of
age and over
10 mL every 12 hours, not to
exceed 20 mL in 24 hours
children 6 to under 12 years of
age
5 mL every 12 hours, not to
exceed 10 mL in 24 hours
children 4 to under 6 years of
age
2.5 mL every 12 hours, not to
exceed 5 mL in 24 hours
children under 4 years of age
do not use
OTHER INFORMATION
each 5 mL contains: SODIUM 7 MG
store at 20-25°C (68-77°F)
dosing cup provided
INACTIVE INGREDIENTS
citric acid anhydrous, D&C red no. 33, edetate disodium,
ethylcellulose, FD&C blue no. 1,
flavor, high fructose corn s