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  5. Label Information: Biocotron

FDA Label for Biocotron

View Indications, Usage & Precautions

Table of Contents

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

Biocotron 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 5 mL tsp.)              Purpose

Dextromethorphan Hydrobromide 10 mg.................. Cough Suppressant

Guaifenesin 100 mg .............................................. Expectorant


Otc - Purpose



Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings



Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    • When using this product, do not exceed recommended dosage

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Otc - Do Not Use



Do not Use

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 you are taking a prescription drug that contains an MAOI;
ask your doctor or pharmacist before taking this product.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Dosage & Administration



Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician

adults and children 12 years and over, 2 teaspoonfuls every 4 hours

children 6 years to under 12 years, 1 teaspoonful every 4 hours

children under 6 years, ask a doctor

Indications & Usage



Other information store at controlled room temperature
20-25 C (68-77 F); excursion permitted to 15-30 C (59-86 F). Tamper
evident by imprinted heat seal under cap. Do not use if there is
evidence of tampering.
Warning: Phenylketonuric: Contains 11.25 mg of phenylalanine per 5 ml (one teaspoonful) dose.


Inactive Ingredient



Inactive ingredients Aspartame, citric acid, flavor, glycerine,
hydroxyethylcellulose, methylparaben, propylene glycol, purified
water and sodium citrate.


Otc - Questions



Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com


* Please review the disclaimer below.