Guaifenesin Dm Liquid
FDA Label NDC 71800-057

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovida Pharmaeutique Corporation for the product Guaifenesin Dm (NDC 71800-057). 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 ingredient (in each 5ml tsp), purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments? 1-888-462-4166, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5Ml Tsp)

Dextromethorphan HBr. USP 10 mg
Guaifenesin USP 100 mg

Purpose

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

Warnings

Do not useif 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 ifcough 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 healthcare 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. (1-800-222-1222)

Directions

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

 Adults and Children 12 years of age and over 10mL (2 teaspoonfuls every 4 hours or as directed by doctor)
 Children under 12 years of age Do not use

Other Information

  • store at room temperature
  • 15° to 30°C (59° to 86°F) TAMPER-EVIDENT;
  • do not use if seal under cap is torn broken or missing.

Inactive Ingredients

CITRIC ACID, FD&C RED NO. 40, GLYCERIN, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, Strawberry Flavor, SUCRALOSE

Questions Or Comments? 1-888-462-4166

Product Label

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