Ventolin Syrup

(Generic versions may still be available.)

DRUG DESCRIPTION

VENTOLIN Syrup (albuterol sulfate syrup) contains albuterol sulfate, USP, the racemic form of albuterol, a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name a1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-a,a1-diol sulfate (2:1) (salt), and the following chemical structure:

The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organizations recommended name for albuterol base is salbutamol.

VENTOLIN Syrup (albuterol sulfate syrup) for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). The inactive ingredients for VENTOLIN Syrup (albuterol sulfate syrup) include: citric acid, USP anhydrous; FD&C Yellow No. 6; flavor strawberry artificial F-8636; hydroxypropyl methylcellulose 2906 or 2910, USP; saccharin, NF; sodium benzoate, NF; sodium citrate, USP dihydrate; and water purified, USP. The pH of the syrup is between 3.0 and 4.5.

What are the precautions when taking albuterol sulfate syrup (Ventolin Syrup)?

Before taking albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (such as metaproterenol, terbutaline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as irregular heartbeat, angina, heart attack), high blood pressure, diabetes, seizure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery,...

Read All Potential Precautions of Ventolin Syrup


Ventolin Syrup Consumer (continued)

SIDE EFFECTS: Nervousness, shaking (tremor), headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat.

Get medical help right away if you have any rare but very serious side effects, including: chest pain, irregular heartbeat.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (such as metaproterenol, terbutaline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as irregular heartbeat, angina, heart attack), high blood pressure, diabetes, seizure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.



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