DELSYM AND CHILDRENS DELSYM dextromethorphan

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS)

Available from:

Reckitt Benckiser LLC

INN (International Name):

Dextromethorphan

Composition:

Dextromethorphan Hydrobromide 30 mg in 5 mL

Prescription type:

OTC DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

DELSYM AND CHILDRENS DELSYM- DEXTROMETHORPHAN
RECKITT BENCKISER LLC
----------
DELSYM AND CHILDREN'S DELSYM (DEXTROMETHORPHAN)
EXTENDED-RELEASE SUSPENSION
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan
hydrobromide
PURPOS E
Cough suppressant
US ES
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 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, cough 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
mL = milliliter
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
5 mL every 12 hours,
®
®
12 years of age
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 (DELSYM ORANGE FLAVORED LIQUID)
citric acid, edetate disodium, ethylcellulose, FD&