Guaifenesin Dm Syrup
FDA Label NDC 60687-828

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Guaifenesin Dm (NDC 60687-828). 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 10 ml cup), purpose, uses, warnings, 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 Ingredient (In Each 10 Ml Cup)

Guaifenesin 200 mg
Dextromethorphan Hydrobromide 20 mg

Purpose

Expectorant
Cough Suppressant

Uses

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

Warnings

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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • you are hypersensitive to any of the ingredients.

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.

Directions

Follow dosage below or use as directed by a physician.

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

    • Age (yr)

    Dose (mL)

    adults and children 12 years and over

    10 mL (2 teaspoonfuls) every 4 hours

    children 6 years to under 12 years

    5 mL (1 teaspoonful) every 4 hours

    children 2 years to under 6 years

    2.5 mL (1/2 teaspoonful) every 4 hours

    children under 2 years

    ask a doctor

Other Information

  • Each 10 mL contains: sodium 8 mg
  • Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
  • DO NOT USE IF SEAL IS BROKEN.
  • Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup and is available in the following dosage forms:
    5 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-817-17
    10 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-828-56

Inactive Ingredients

citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Questions Or Comments?

Call 1-800-845-8210

Other

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Distributed by:
American Health Packaging
Columbus, OH 43217

R0324

Package/Label Principal Display Panel - Label

Guaifenesin And Dextromethorphan Syrup Label (Label)

Guaifenesin And Dextromethorphan Syrup Label (Label)

Case NDC 60687-828-56/Cup NDC 60687-828-42

GUAIFENESIN and
DEXTROMETHORPHAN
SYRUP

Expectorant/Cough Suppressant

200 mg/20 mg per 10 mL

Non-Narcotic, Alcohol Free
Cherry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0638C100324                 R03/24

Package/Label Principal Display Panel – Cup Lid – 200 Mg/20 Mg Per 10 Ml

NDC 60687- 828-42

Guaifenesin and
Dextromethorphan Syrup

Expectorant/cough Suppressant

200 mg/20 mg per 10 mL

Sodium Content: 8 mg/10 mL

Delivers 10 mL

Protect from light

See package Drug Facts insert for full
prescribing information and storage

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0638C100224

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