S2- racepinephrine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (RACEPINEPHRINE - UNII:GR0L9S3J0F)

Available from:

Cardinal Health

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

OTC DRUG

Therapeutic indications:

Bronchodilator For temporary relief of mild symptoms of intermittent asthma:

Authorization status:

OTC monograph final

Summary of Product characteristics

S2- RACEPINEPHRINE HYDROCHLORIDE SOLUTION
CARDINAL HEALTH
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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RACEPINEPHRINE INHALATION SOLUTION, USP 2.25%
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 0.5 ML)
Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).
PURPOS E
Bronchodilator
US ES
For temporary relief of mild symptoms of intermittent asthma:
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WARNINGS
ASTHMA ALERT
BECAUSE ASTHMA MAY BE LIFE THREATENING, SEE A DOCTOR IF YOU:
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These may be signs that your asthma is getting worse.
DO NOT USE:
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ASK A DOCTOR BEFORE USE IF YOU HAVE:
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Wheezing
Tightness of chest
Shortness of breath
Are not better in 20 minutes
Get worse
Need more than 12 inhalations in 24 hours
Use more than 9 inhalations in 24 hours for 3 or more days a week
Have more than 2 asthma attacks in a week
Unless a doctor said you have asthma
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 a MAOI, ask a
doctor or pharmacist before taking this product.
If product is brown in color or cloudy
Ever been hospitalized for asthma
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE:
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STOP USE AND ASK A DOCTOR IF:
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WHEN USING THIS PRODUCT:
YOUR BLOOD PRESSURE OR HEART RATE MAY GO UP. THIS COULD INCREASE YOUR
RISK OF HEART ATTACK OR
STROKE, WHICH MAY CAUSE DEATH.
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DIRECTIONS
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Heart disease
High blood pressure
Diabetes
Thyroid disease
Seizures
Narrow angle glaucoma
A psychiatric or emotional condition
Trouble urinating due to an enlarged prostate gland
Taking prescription drugs for asthma, obesity, weight control,
depression, or psychiatric or
emotional