SPL v1
SPL
SPL Set ID 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb
Route
ORAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 4 Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-12

Description

10 mg-100 mg/5 mL - Active ingredient per 5 mL (1 unit dose)  Dextromethorphan HBr. 10 mg Guaifenesin 100 mg 20 mg-200 mg/10 mL - Active ingredient per 10 mL (1 unit dose)     Dextromethorphan HBr. 20 mg Guaifenesin 200 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Dosage and Administration

Directions

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

20 mg-200 mg/10 mL

age dose
Children under 12 years of age

Do not use

Adults and children over 12 years of age

10 mL (1 unit dose) every 4 hours

10 mg-100 mg/5 mL

age dose
Children under 6 years of age Do not use
Children 6 to under 12 years of age 5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age 10 mL (2 unit dose) every 4 hours

Description

10 mg-100 mg/5 mL - Active ingredient per 5 mL (1 unit dose)  Dextromethorphan HBr. 10 mg Guaifenesin 100 mg 20 mg-200 mg/10 mL - Active ingredient per 10 mL (1 unit dose)     Dextromethorphan HBr. 20 mg Guaifenesin 200 mg

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

Section 50565-1

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)

Section 50566-9

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

Section 50570-1

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.

Section 51727-6

Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

Section 53413-1

Questions or comments? Call (866) 838-3774

Section 53414-9

If pregnant or breast-feeding, ask a healthcare professional before use.

Section 60561-8

Other Information

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   do not use if lid is torn or broken

Drug Facts

10 mg-100 mg/5 mL -

Active ingredient per 5 mL(1 unit dose) 

Dextromethorphan HBr. 10 mg

Guaifenesin 100 mg

20 mg-200 mg/10 mL -

Active ingredient per 10 mL(1 unit dose)    

Dextromethorphan HBr. 20 mg

Guaifenesin 200 mg

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

Package Label.principal Display Panel

EverPharm

NDC 84415-014-01

Dextromethorphan HBr. 

and Guaifenesin 

Oral Solution

Cough Suppressant/

Expectorant

10 mg-100 mg/5 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 5 mL Unit-Dose Cups


Structured Label Content

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

Dosage and Administration (34068-7)

Directions

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

20 mg-200 mg/10 mL

age dose
Children under 12 years of age

Do not use

Adults and children over 12 years of age

10 mL (1 unit dose) every 4 hours

10 mg-100 mg/5 mL

age dose
Children under 6 years of age Do not use
Children 6 to under 12 years of age 5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age 10 mL (2 unit dose) every 4 hours

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

Section 53413-1 (53413-1)

Questions or comments? Call (866) 838-3774

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a healthcare professional before use.

Section 60561-8 (60561-8)

Other Information

•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   do not use if lid is torn or broken

Purpose

Cough Suppressant

Expectorant

Drug Facts (DRUG FACTS)

10 mg-100 mg/5 mL -

Active ingredient per 5 mL(1 unit dose) 

Dextromethorphan HBr. 10 mg

Guaifenesin 100 mg

20 mg-200 mg/10 mL -

Active ingredient per 10 mL(1 unit dose)    

Dextromethorphan HBr. 20 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have (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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

EverPharm

NDC 84415-014-01

Dextromethorphan HBr. 

and Guaifenesin 

Oral Solution

Cough Suppressant/

Expectorant

10 mg-100 mg/5 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 5 mL Unit-Dose Cups


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)