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  5. Label Information: Bio-s-pres DX

FDA Label for Bio-s-pres DX

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. INDICATIONS & USAGE
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bio-s-pres DX Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Generic Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients (in each 1mL)                   Purpose

Dextromethorphan HBr, 5 mg ................................. Cough Suppressant

Guaifenesin, 50 mg ................................................ Expectorant

Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant




Otc - Purpose



Purpose

Cough Suppressant

Expectorant

Nasal Decongestant


Warnings



Warnings:


Do not exceed recommended dosage.

  • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
  • If symptoms do not improve within 7 days or accompanied by fever, consult a doctor.

Otc - Do Not Use



  • Do not use this product:for persistent or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • Do not give this product to child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
  • Stop use and ask a doctor:
  • A persistent cough may be a sign of a serious condition;
  • If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions:Do not exceed more than 6 doses in any 24-hour period. Measure with the dosage device provided. Do not use with any other device.

Age
Dose
Children 2 to under 6 years of age
1 mL every 4 hours
Children under 2 years of age
Consult a doctor

Inactive Ingredient



Inactive ingredients:Artificial  and natural Cherry Flavor, Citric Acid, FD and C Red No. 40, Glycerin, Methyl Paraben (as preservative), Propylene Glycol, Propylparaben (as preservative), Purified Water, sodium citrate, Sand sucralose


Otc - Questions



Questions or comments? 1-305-403-3788


Indications & Usage



Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.


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