dd3f806b-2470-4055-94e1-18adac811025

SPL v1
SPL
SPL Set ID dd3f806b-2470-4055-94e1-18adac811025
Route
oral
Published
Effective Date 2025-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (100 mg)
Inactive Ingredients
citric acid fd&c red no. 40 glycerin menthol methylparaben potassium sorbate propylene glycol propylparaben water sodium citrate sucralose strawberry

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-20

Purpose

Cough Suppressant Expectorant

Description

Dextromethorphan HBr. USP 10 mg Guaifenesin USP 100 mg


Medication Information

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)

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
Purpose

Cough Suppressant

Expectorant

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

Description

Dextromethorphan HBr. USP 10 mg Guaifenesin USP 100 mg

Section 50565-1

Product Label

Active Ingredient (in Each 5ml Tsp)

Dextromethorphan HBr. USP 10 mg

Guaifenesin USP 100 mg

Questions Or Comments? 1 888 462 4166


Structured Label Content

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)

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
Purpose

Cough Suppressant

Expectorant

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

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient (in Each 5ml Tsp) (Active Ingredient (in each 5mL tsp))

Dextromethorphan HBr. USP 10 mg

Guaifenesin USP 100 mg

Questions Or Comments? 1 888 462 4166 (Questions or Comments? 1-888-462-4166)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)