OTC Medication Information: VASOPRO EPHEDRINE

VASOPRO EPHEDRINE- ephedrine hydrochloride and guaifenesin tablet
Optimal Research Inc

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.

Drug Facts

Active Ingredients (in each tablet)

Ephedrine Hydrochloride 25mg

Guaifenesin 200mg

Purpose

Bronchodilator

Expectorant

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center immediately.

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.

Inactive Ingredients: Colloidal silicon dioxide, Croscarmellose sodium, Magnesium stearate, Maltodextrin, Microcrystalline cellulose

Povidone, Pregelatinized corn starch, Stearic acid.

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
(click image for full-size original)

VASOPRO EPHEDRINE
ephedrine hydrochloride, guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70258-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPHEDRINE HYDROCHLORIDE (EPHEDRINE) EPHEDRINE HYDROCHLORIDE 25 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score 4 pieces
Shape ROUND Size 9mm
Flavor Imprint Code MP101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70258-320-24 1 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 24 TABLET in 1 BLISTER PACK This package is contained within the BOX (70258-320-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/23/2015
Labeler — Optimal Research Inc (612492678)
Establishment
Name Address ID/FEI Operations
Pharmatech Llc 968082094 manufacture (70258-320)

Revised: 11/2015 Optimal Research Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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