Bionatuss
FDA Label NDC 45737-210

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 Bionatuss (NDC 45737-210). 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.)                                           Purpose

Dexbrompheniramine Maleate.............2mg................................Antihistamine

Dextromethorphan HBr..................20mg.................................Cough Suppressant

Phenylephrine HCL......................10mg................................. Nasal Descongestant

Otc - Purpose

Uses

Temporarily relieves cough due to minor throat and bronchial
irritations as may occur with the common cold !"temporarily relieves nasal
congestions due to the common cold"!"for temporary relief of runny nose,
sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
or allergic rhinitis.


Warnings

Warnings:

When using this product, do not exceed recommended dosage.
Stop use and ask a doctor if
  • your child gets nervous, dizzy or sleepless
  • condition lasts for more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

    • Warning: Phenylketonuric: Contains 6.25 mg of Phenylalanine per 5mL (one teaspoonful) dose.

Otc - Do Not Use

Do not use in a child who is 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. May cause
excitability especially in children. Do not take this product, if you have a breathing problem such as emphysema or
chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland, heart disease,
high blood pressure, diabetes or thyroid disease, unless directed by a doctor. May cause drowsiness; alcohol,
sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution
when driving a motor vehicle or operating machinery.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help orcontact 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: Do not exceed more than 6 doses in any 24-hour period or
as directed by a doctor.

  Adults and children
 12 years of age and over
  take 1 teaspoonful (5 mL)
 every 4 hours
  Children 6 to under
 12 years of age
  take 1/2 teaspoonful (2.5 mL)
 every 4 hours
  Children under 6 years of age
  ask a doctor

Indications & Usage

Other informationStore at room temperature 15- 30 degree Celsius (59 - 86 degree Farenheit). Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering. Alcohol Free and Phenylpropanolamine (PPA) Free.

Inactive Ingredient

Inactive ingredients: Ammonium glycyrrhizinate, aspartame, D and C Red #33, flavor, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucrose.

Otc - Questions

Questions or comments? 1-305-403-3788

* Please review the disclaimer below.