DELSYM (DEXTROMETHORPHAN)- dextromethorphan suspension, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
08-04-2024

Aktivna sestavina:

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

Dostopno od:

RB Health (US) LLC

Pot uporabe:

ORAL

Tip zastaranja:

OTC DRUG

Terapevtske indikacije:

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

Status dovoljenje:

New Drug Application

Lastnosti izdelka

                                DELSYM (DEXTROMETHORPHAN)- DEXTROMETHORPHAN SUSPENSION, EXTENDED
RELEASE
RB HEALTH (US) LLC
----------
DELSYM
(DEXTROMETHORPHAN) SUSPENSION
EXTENDED-RELEASE
_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 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
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 IFcough 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, edetate disodium, ethylcellulose, FD&C yellow no. 6,
flavor, high fructose corn
syrup, met
                                
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