Scot-tussin
FDA Label NDC 0372-0036

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Scot-tussin Pharmacal Co., Inc. for the product Scot-tussin (NDC 0372-0036). 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, purpose, uses, warnings, do not use, ask a doctor before use is you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each 5 mL. tsp. teaspoon)

*Chlorpheniramine Maleate USP 2mg

Dextromethorphan HBr. USP 15mg 

Purpose

Antihistamine

Cough Suppressant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. Quiets and calms a dry cough.
  • Temporarily relieves runny nose and sneezing, itching of the nose and throat, and itchy watery eyes due to upper respiratory symptoms.

Warnings

DO NOT USE THIS PRODUCT TO SEDATE CHILDREN

Do Not Use

  • more than the recommended dosage.
  • if you are 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 pharmacists before taking this product.

Ask A Doctor Before Use Is You Have

  • Persistent or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, or if cough is accompanied by excessive phlegm (mucus).
  • Difficulty in urination due to enlargement of the prostate gland.
  • Glaucoma.
  • Thyroid disease.

When Using This Product

  • May cause drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. If you are taking sedatives or tranquilizers, consult your doctor before taking this medicine. Use caution when driving a motor vehicle or operating machinery.

Stop Use And Ask A Doctor If

  • Chough lasts more than seven days, returns or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Do Not Use.

Keep Out Of Reach Of Children.

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

Directions:

  • Follow Dosage Chart.
  • Do not take more than 4 doses in any 24 hour period.
  • This product is not intended for use in children under 12 years of age.
    • agedose
    Adults and children
    over 12 years old    		2 teaspoons
    (2 tsp. 10 ml)
    every 6 hours
    Children Under
    12 years old    		DO NOT USE

Other Information

  • Store at 20° – 25° C (68° – 77° F).
  • Do not refrigerate.
  • Dosage cup provided.

Inactive Ingredients

Ammonium Glycrrhizate, Citric Acid, Clear Cherry-Strawberry Flavor, Glycerin, Hydroxyethylcellulose, Menthol, Methyl Paraben, Potassium Benzoate, Propyl Paraben, Propylene Glycol, Purified Water.

Principal Display Panel

NDC 0372-0036-04

SCOT-TUSSIN

DM

Maximum Strength
COUGH SUPPRESSANT & COLD RELIEF

4 FL OZ (118 ml)

Principal Display Panel (Scot Tussin Dm Sf Maximum Strength Cough Cold 01)

Principal Display Panel (Scot Tussin Dm Sf Maximum Strength Cough Cold 01)

* Please review the disclaimer below.