Vasopro Ephedrine
FDA Label NDC 70258-320
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Optimal Research Inc for the product Vasopro Ephedrine (NDC 70258-320). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each tablet), purpose, otc - keep out of reach of children, indications & usage, warnings:, directions:, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Tablet)
Ephedrine Hydrochloride 25mg
Guaifenesin 200mg
Purpose
Bronchodilator
Expectorant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center immediately.
Indications & Usage
Uses: • Temporarily relieves shortness of breath, tightness of chest, and wheezing due to bronchial asthma
• Eases breathing for asthma patients • Helps loosen mucus and thin bronchial secretions to drain bronchial tubes.
Warnings:
Do not use this product • unless a diagnosis of asthma has been made by a doctor
• If seal is not intact or punctured.
Ask a doctor before use if you have
• heart disease • high blood pressure • thyroid disease • diabetes
• difficulty in urination due to enlargement of the prostate gland.
Ask a doctor before use if • you have been hospitalized for asthma
• you are taking any prescription drug for asthma.
Stop use and ask a doctor if • symptoms do not get better within 1 hour or become worse
• you get nervous or sleepless, have tremors or nausea, or lose your appetite
• 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.
Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma,
chronic bronchitis, or emphysema • cough with excessive mucus
If pregnant or breast-feeding, ask a health care professional before use.
Do not use if you are taking any 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 don’t know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Directions:
• Adults and children 12 years of age and over. Take 1 tablet every 4 hours: do not take more than 6 tablets in 24 hours
• Children under 12 years of age: Consult a doctor.
Other
Tamper evident, do not use if blister seals are not intact
Maximum Sale Allowed 2 Boxes Per Transaction
MEGA-PRO®
INTERNATIONAL
Maximum Strength
VASOPRO
EPHEDRINE
Expectorant / Bronchodilator
24 Tablets
DO NOT SELL TO MINORS
ABUSE OF THIS PRODUCT COULD BE FATAL
Distribution of this product requires a DEA License.
Distributed by: Mega-Pro International®, St. George, UT 84770
Packaging
Vasopro (Vasopro)
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