280r - Kroger Mucus Relief Dm

280r - Kroger Mucus Relief Dm
SPL v2
SPL
SPL Set ID 813baf42-edb0-33a9-e053-2a91aa0a8599
Route
ORAL
Published
Effective Date 2019-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Potato Magnesium Stearate Maltodextrin Microcrystalline Cellulose Povidone Stearic Acid Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL280 Shape: oval Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-06-03

Description

Each immediate-release tablet contains Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

Helps loosen phlegm (mucus)

Helps thin bronchial secretions to make coughs more productive

Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Dosage and Administration

Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

Description

Each immediate-release tablet contains Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Section 50565-1
Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center

Section 51727-6

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Section 51945-4

Section 55105-1

Expectorant – Cough Suppressant

Section 55106-9

Each immediate-release tablet contains

Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Structured Label Content

Indications and Usage (34067-9)

Helps loosen phlegm (mucus)

Helps thin bronchial secretions to make coughs more productive

Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Dosage and Administration (34068-7)

Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)
Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center

Section 51727-6 (51727-6)

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Expectorant – Cough Suppressant

Section 55106-9 (55106-9)

Each immediate-release tablet contains

Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)