Altipres
FDA Label NDC 53163-103

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 Altipres (NDC 53163-103). 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 ............... 5 mg ................ Cough Suppressant

Guaifenesin .............................. 75 mg ................ Expectorant

Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Warnings

Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to the enlargement of the prostate gland
  • a cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema

    • When using this product, do not exceed recommended dosage

    Stop use and ask doctor if

    • your child gets 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 headache. These could be signs of a serious condition

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 taking this product -Do not use- in a child under 2 years of age.

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

Indications

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves nasal congestion due to the common cold

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 4 teaspoonfuls (20 mL) every 4 hours
children 6 to under 12 years of age
take 2 teaspoonful (10 mL) every 4 hours
children 2 years to under 6 years of age
take 1 teaspoonful (5 mL) every 4 hours
children under 2 years of age
ask a doctor

Inactive Ingredient

Inactive ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

Otc - Questions

Questions or comments? 1-305-403-3788

Package Label.Principal Display Panel

Altiprespediatric (Altipresped)

Altiprespediatric (Altipresped)

* Please review the disclaimer below.