Igualtuss
FDA Label NDC 53163-106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alternative Pharmacal Corporation for the product Igualtuss (NDC 53163-106). 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 - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, dosage & administration, 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

Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant

Guaifenesin .............................. 388 mg ................ Expectorant

Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant

Otc - Purpose

Purpose 

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Warnings

  • Do not exceed recommended dosage
  • A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reccur or is accompanied by a fever, rash or persistent headache, consult a doctor
  • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor

    • When using this product, do not exceed recommended dosage

Otc - Do Not Use

Do not use

  • For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
  • If you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by doctor
  • 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

    • If you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to the enlargment of the prostate gland unless directed by a doctor.

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

Indications & Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
  • temporarily relieves nasal congestion and cough due to minor throat and bronchial irritation ocurring with the common cold or inhaled irritants.

Dosage & Administration

Directions  Do not exceed more than 6 doses in any 24-hour period

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

Inactive Ingredient

Inactive ingredients: Citric acid, FD&C Yellow #6, flavor, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, glycerine and sucralose

Otc - Questions

Questions or comments? 1-786-507-1566

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