FDA Label for Guaifenesin Dm

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

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