Bio Dtuss
FDA Label NDC 45737-203

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Bio Dtuss (NDC 45737-203). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients(in each 5 mL tsp.)                                         PurposeBrompheniramine Maleate...................... 1mg ..................................AntihistamineDextromethorphen HBr........................... 20 mg ............................Cough SuppressantPseudoephedrine HCl............................. 30mg .............................Nasal Decongestant

Otc - Purpose

Uses:

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies or associated with sinusitis
  • Temporarily relieves these symptoms due to hay fever(allergies rhinitis)
  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy of the nose or throat
  • Temporarily restores free breathing through the nose

Warnings


Warnings:

  • May cause excitability especially in children. May cause drowsiness, alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcohol beverages while taking this product. Do not take this product if you have taken sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
  • Do not exceed recommended dosage. 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 - Do Not Use

Do Not Use:


Ask a doctor before use if you have:

  • Cough that occurs with too much phlegm (mucus)
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Glaucoma
  • Trouble urinating due to an enlarged prostate gland
  • A breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • Stop use and ask a doctor if:

    • You get nervous, dizzy or sleepless
    • Symptoms do not get better within 7 days, comes back, or is accompaniend by fever, rash or persistent headache. These could be signs of a serious condition

Otc - Keep Out Of Reach Of Children

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

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration


Directions:

 adults and children 12 years of age and over
 take 1 teaspoonfull every 6 hours
 children 6 to under 12 years of age
 take 1/2 teaspoonfull every 6 hours
 children under 6 years of age
 ask doctor

Indications & Usage

Other Information:

  • store at room temperature 15-30 degrees celcius (59-86 degrees farenheit)
    • Tamper Evident Feature Do not use if seal under cap(or cello band over cap) is torn, broken or missing.

Inactive Ingredient

 Inactive Ingredients:

 Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sucrose, Citric Acid, Sodium Citrate, D and C Red #33, FD and C Blue #1, Grape Flavor and Purified Water.

Otc - Questions

Question and Comments? 1-305-403-3788

Advanced Generic Corporation, Miami, FL 33166

www.advancedgeneric.com

Package Label.Principal Display Panel

Biodtusslabel (Biodtusslabel)

Biodtusslabel (Biodtusslabel)

* Please review the disclaimer below.