Bio-rytuss Liquid
FDA Label NDC 45737-250

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-rytuss (NDC 45737-250). 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.

Otc - Active Ingredient

Active ingredients (in each 5 mL tsp.)                 Purpose

Chlorpheniramine Maleate   2 mg                                  Antihistamine

Dextromethorphan Hydrobromide 10 mg                        Cough Suppressant

Phenylephrine Hydrochloride        5 mg                         Nasal Decongestant


Otc - Purpose

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Warnings

Warnings

Ask doctor before use if you have

  • Cough that occurs with too much phlegm (mucus), or a breathing problem or persitent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • Heart disease
  • High blood pressure
  • Thyroid Disease
  • Diabetes
  • Difficulty in urinating due to enlarged prostate gland
  • Glaucoma
  • Ask doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant; taking sedatives or tranquilizers.

    When using this product

    • Do not use more than directed
    • May cause marked drowsiness; avoid alcohol beverages; alcohol, sedatives and tranquilizers may increase drowsiness. 
    • Be careful when driving a motor vehicle or operating machinery; excitability may occur, especially with children.

Otc - Do Not Use

Do not use

  • To sedate a child or to make a child sleepy
  • 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 that contains an MAOI, ask your doctor or pharmacist before taking this product
  • Stop use and ask a doctor if you
    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headaches. 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 immediately

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a doctor before use

Dosage & Administration

Directions do not take more than 6 doses in any 24 hour period

adults and children
12 years of age
2 teaspoonful (10 mL)
every 4-6 hours
children 6 to under
12 years of age
1 teaspoonful (5 mL)
every 4-6 hours
children 2 to under 6 years of age

1/2 teaspoonful (2.5 mL)

every 4-6 hours

Indications & Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis); runny nose; sneezing; itchy watery eyes; itching of the nose or throat
  • temporarily restores freer beathing through the nose.

Inactive Ingredient

Inactive ingredients

Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.

Otc - Questions

Questions or comments?

1-305-403-3788

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Rytusslabel (Biorytussv3)

Rytusslabel (Biorytussv3)

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