Tussin Cough Liquid
FDA Label NDC 57243-503

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Salado Sales, Inc. for the product Tussin Cough (NDC 57243-503). 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 drug factsactive ingredients ( in each 5 ml tsp), purpose, keep out of reach of children., uses, warnings, ask a doctor before you use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients ( In Each 5 Ml Tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough Suppressant
Expectorant

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

Uses

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

Warnings

Do not use

  • in a child under 12 years of age
  • 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

Ask A Doctor Before You Use If You Have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop Use And Ask A Doctor If

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.

If Pregnant Or Breast-Feeding

ask a health professional before use.

Directions

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

    • Age                                       Dose

    adults & children                     2 teaspoonfuls
    12 years and over                  every 4 hours

    children under 12 years           do not use

Other Information

  • store at 20-25° C (66-77° F)
  • do not refrigerate
  • dosage cup provided
  • sodium 3 mg per teaspoon

Inactive Ingredients

Anhydrous citric acid, dextrose, FD & C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Tussin Cough Dm Product Label

* COMPARE TO ROBITUSSIN® PEAK COLD ACTIVE INGREDIENTS


CVP® CONSUMER VALUE PRODUCTS

TUSSIN COUGH EXPECTORANT COUGH SUPPRESSANT DM

NON-DROWSY COUGH FORMULA

  • ADULT
  • FOR AGES 12 AND OVER
  • CONTROLS COUGH
  • HELPS LOOSEN CHEST CONGESTION

    • 4 FL OZ (118 Ml)

    * This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold

    Box-001 Rev 01

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Distributed by: Salado Sales, Inc.  P.O. Box 6115 Temple, TX 76503  www.saladosales.com

    LOT.

    EXP.

* Please review the disclaimer below.