Altipres-b Liquid
FDA Label NDC 53163-101

11 label sections · Submitted to the FDA by Alternative Pharmacal Corporation · 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-b (NDC 53163-101). 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, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, 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

Brompheniramine maleate 4 mg                                Antihistamine

Dextromethorphan HBr 20 mg                                  Cough Suppressant 

Phenylephrine HCl 10 mg                                      Nasal Decongestant

Otc - Purpose

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Indications & Usage

Uses

  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, water eyes
  • nasal congestion
  • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
  • temporarily restores freer breathing through nose

Warnings


Warnings

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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not use on a child under 2 years of age.


Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

    • Ask a doctor or a pharmacist before

    • giving this product to children who are taking sedatives or tranquilizers
    • if you are taking sedatives or tranquilizers

Otc - Do Not Use

Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.

When using this product

  • do not use more than directed
  • may cause drowsiness
  • avoid alcoholic drink
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

    • Stop use and ask a doctor if



    • you get nervous, dizzy or sleeplessness
    • 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 - Keep Out Of Reach Of Children

Keep out of reach of children.In case of accidental 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

DirectionsDo not exceed more than 6 doses in any 24-hour period.

adults and children 12 years of age and over
take 1 teaspoonfuls (5 mL) every 4 hours
children 6 to under 12 years of age
take 1/2 teaspoonfuls (2.5mL) every 4 hours
children 2 years to under 6 years of age
ask a doctor
children under 2 years of age
do not use

Inactive Ingredient

Inactive Ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose

Otc - Questions

Questions or comments: 1-305-403-3788

Alternative Pharmacal Corp. Miami Fl 33147

www.alternativepharmacal.com

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