Stop Cough PLUS

Manufacturer
Plus Distributors LLC
Effective date
2019-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:31:24

Label at a glance#

ProductStop Cough PLUS
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and older  take 1 tablet every 4 hours children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
  • adults and children 12 years of age and older
    •  take 1 tablet every 4 hours
  • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: sodium 20 mg low sodium
  • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucus relief DM

GUAIFENESIN 400 mg, DEXTROMETHORPHAN HBr 20 mg

EXPECTORANT, COUGH SUPPRESSANT

Controls cough

Thins and loosens mucus

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stop Cough PLUS
Stop Cough PLUS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72828-109-302020-12-14C16284748780-1ab0e2407-3106-f274-e053-dbdaa90a6471Drug Facts
72828-109-302020-09-27C16284748780-1ab0e2407-3106-f274-e053-dbdaa90a6471Drug Facts
72828-109-302020-09-25C16284748780-1ab0e2407-3106-f274-e053-dbdaa90a6471Drug Facts
72828-109-302020-07-22C16284748780-1ab0e2407-3106-f274-e053-dbdaa90a6471Drug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72828-10972828-109-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1a87be16-542a-42cb-9a30-2e068a8d4c59f164fd82-bffe-4a68-be1e-ef9fe0b667222020-12-14WarningsExact identifier
spl set id: f164fd82-bffe-4a68-be1e-ef9fe0b66722

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.