SPL v1
SPL
SPL Set ID 32fa7a09-8624-44c1-b9e4-8a8f0594292b
Route
ORAL
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Stevia Leaf Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

(in each 3 mL) (one dose) Dextromethrophan HBr, 30 mg

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Dosage and Administration

Directions

• do not exceed 120 milligrams (4 doses) in any 24-hour period

• measure only 3 mL with dosing syringe provided

• only use this product according to these directions

 age dose

 adults and children 12 years and over

 3mL every 6 to 8 hours 

 children under 12 years 

 do not use

Description

(in each 3 mL) (one dose) Dextromethrophan HBr, 30 mg

Uses
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Section 50565-1

Warning

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

• a cough that is accompanied by excessive phlegm (mucus), or

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Stop use and ask a doctor ifa cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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. (1-800-222-1222)

Product Label

Active Ingredient

(in each 3 mL) (one dose) Dextromethrophan HBr, 30 mg

Other Information 

TAMPER EVIDENT: Do not use if seal on the bottle is broken.

• store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose

Questions Or Comments?

833-289-7626 between 10 a.m. to 4 p.m. CST, Monday-Friday


Structured Label Content

Uses
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Dosage and Administration (34068-7)

Directions

• do not exceed 120 milligrams (4 doses) in any 24-hour period

• measure only 3 mL with dosing syringe provided

• only use this product according to these directions

 age dose

 adults and children 12 years and over

 3mL every 6 to 8 hours 

 children under 12 years 

 do not use

Section 50565-1 (50565-1)

Purpose

Cough suppressant

Warning

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

• a cough that is accompanied by excessive phlegm (mucus), or

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Stop use and ask a doctor ifa cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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. (1-800-222-1222)

Product Label (Product label)

Active Ingredient (Active ingredient)

(in each 3 mL) (one dose) Dextromethrophan HBr, 30 mg

Other Information  (Other information )

TAMPER EVIDENT: Do not use if seal on the bottle is broken.

• store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose

Questions Or Comments? (Questions or comments?)

833-289-7626 between 10 a.m. to 4 p.m. CST, Monday-Friday


Advanced Ingredient Data


Raw Label Data

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