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Tussin cough expectorant cough supressant dm - Medication Information

Product NDC Code 57243-503
Drug Name

Tussin cough expectorant cough supressant dm

Type Brand
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE],
Sigma-1 Agonist [EPC],
Sigma-1 Receptor Agonists [MoA],
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],
Uncompetitive NMDA Receptor Antagonists [MoA]
Active Ingredients
Dextromethorphan hydrobromide 10 mg/5ml
Guaifenesin 100 mg/5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 996520
Application Number M012
Labeler Name Salado Sales, Inc.
Packages
Package NDC Code Description
57243-503-24 118 ml in 1 bottle (57243-503-24)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug FactsActive ingredients ( in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Anhydrous citric acid, dextrose, FD & C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Cough Suppressant Expectorant

Spl product data elements

Usually a list of ingredients in a drug product.
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID DEXTROSE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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. res AptaSS TussinDM 503 AptaSS TussinDM 503 1

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store at 20-25° C (66-77° F) do not refrigerate dosage cup provided sodium 3 mg per teaspoon

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If Pregnant Or Breast-Feeding ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API