Topcare Tussin Dm Max Solution
FDA Label NDC 36800-847

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Tussin Dm Max (NDC 36800-847). 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 20 ml), purposes, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant 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 20 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes

Cough suppressant

Expectorant

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

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.

Ask A Doctor Before 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

    • age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

Other Information

  • each 20 mL contains: sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

acetic acid, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

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Package/Label Principal Display Panel

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS

PEAK COLD

SEE NEW DOSING

NON-DROWSY

Tussin DM Max

Cough & Chest Congestion DM

COUGH SUPPRESSANT-DEXTROMETHORPHAN HBr

EXPECTORANT-GUAIFENESIN

MAXIMUM STRENGTH

OUR PHARMACISTS RECOMMEND

RELIEVES:

Cough

Mucus

Adult

For Ages 12 & Over

4 FL OZ (118 mL)

RASPBERRY MENTHOL FLAVOR

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