Supress A Syrup
FDA Label NDC 52083-057

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Supress A (NDC 52083-057). 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 active ingredients (in each 1 ml), purpose, uses, warnings, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 1 Ml)

Dexbrompheniramine Maleate, 1 mg

Dextromethorphan HBr, 10 mg

Phenylephiren HCl, 5 mg

Purpose

Antihistamine

Cough suppressant

Expectorant

Uses

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

Warnings

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.

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
    • When using this product
    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedative and tranquilizers may increase drowsiness effect

Otc - Stop Use

Stop use and ask a doctor if

  • nervousness dizziness, or sleeplessness occur
  • new symptoms occur
  • symptoms do not improve 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 - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Children 6 to under 12 years of age

  • 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor
  • Children under 6, consult a doctor.
  • measure with the dosage device provided. Do not use any other device

Other Information

  • Tamper evident feature: Do not use if inner seal is torn, broken or missing.
  • Store at controlled room temperature 15°-30°C (59° to 86°F).
  • Avoid excessive heat and humidity.

Inactive Ingredients

Citric acid, flavor, glycerin, methylparaben, polysorbate, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.

Other

Made in the USA for Kramer Novis.

San Juan, PR 00917

(787) 767-2072 / www.kramernovis.com

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