FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Oral Solution

Manufacturer
Major Pharmaceuticals | Plastikon Healthcare, LLC
Effective date
2021-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:22:16

Label at a glance#

ProductGuaifenesin and Dextromethorphan Oral Solution
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure2 sections

Label contents#

Full prescribing information#

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product TrayProduct TrayNCD 0904-6844-70

Guaifenesin and Detromethorphan Oral Solution

100-10 mg/5 mL

Delivers 5 mL

See Insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Alcohol Free

Guaif DM - 5 mL Cup LidGuaif DM - 5 mL Cup Lid

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL cup

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not exceed the maximum recommended daily dose in a 24 hour period
  • shake well before use

Age (yr)

Dose (mL)

adults and children 12 years and over

10 mL every 4 hours or 15 mL every 6 hours

Max dose is 60 mL in 24 hr

children 6 years to under 12 years

5 mL every 4 hours

Max does is 30 mL in 24 hr

under 6 years

Ask a doctor

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

INSTRUCTIONS FOR USE SECTION

IFU Guaif DM - 5 mLIFU Guaif DM - 5 mL

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

WARNINGS SECTION

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

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

_________________________________________________________________

Ask a doctor or pharmacist before use if you are taking any other drug. ___________________________________________________________________

Stop use and ask a doctor if

  • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

INACTIVE INGREDIENT SECTION

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

INDICATIONS & USAGE SECTION

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL cup)

Guaifenesin 100 mg

Dextromethorphan hydrobromide 10 mg

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

OTC - PURPOSE SECTION

Purpose

Expectorant

Cough Suppressant

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

OTHER SAFETY INFORMATION

Other information

  • each 5 mL contains: sodium 20 mg
  • store at 20-25°C (68-77°F)
  • protect from excessive moisture
  • do not use if lid seal is open or damaged
  • sugar free, dye free, alcohol free
  • see bottom of cup for lot number and expiration date

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TrayTrayGuaif DM - 10 mL cup LidGuaif DM - 10 mL cup LidNCD 0904-6980-72

Guaifenesin and Detromethorphan Oral Solution

200-20 mg/10 mL

Delivers 10 mL

See Insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Alcohol Free

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not exceed the maximum recommended daily dose in a 24 hour period
  • shake well before use

Age (yr)

Dose (mL)

adults and children 12 years and over

10 mL every 4 hours

Max dose is 60 mL in 24 hr

children under 12 years

Ask a doctor

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

WARNINGS SECTION

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

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

_________________________________________________________________

Ask a doctor or pharmacist before use if you are taking any other drug. ___________________________________________________________________

  • Stop use and ask a doctor if
  • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.
  • you are hypersensitive to any of the ingredients

___________________________________________________________________

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

Guaifenesin Dextromethorpan hydrobromide 200/20 mg/10 mL

INACTIVE INGREDIENT SECTION

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

INDICATIONS & USAGE SECTION

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 10 mL cup)

Guaifenesin 200 mg

Dextromethorphan hydrobromide 20 mg

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

OTC - PURPOSE SECTION

Purpose

Expectorant

Cough Suppressant

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

OTHER SAFETY INFORMATION

Other information

  • each 10 mL contains: sodium 40 mg
  • store at 20-25°C (68-77°F)
  • protect from excessive moisture
  • do not use if lid seal is open or damaged
  • sugar free, dye free, alcohol free
  • see bottom of cup for lot number and expiration date

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

INSTRUCTIONS FOR USE SECTION

IFU Guaif DM - 10 mLIFU Guaif DM - 10 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0904-6844-702022-09-23C16284748780-1e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4eMajor Pharmaceuticals Unit Dose OTC Monograph Guaifenesin DM 200/20 mg/ 10 mL Guaifenesin DM 100/10 mg/ 5 mL
0904-6980-722022-09-23C16284748780-1e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4eMajor Pharmaceuticals Unit Dose OTC Monograph Guaifenesin DM 200/20 mg/ 10 mL Guaifenesin DM 100/10 mg/ 5 mL
0904-6844-702022-07-29C16284748780-1e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4eMajor Pharmaceuticals Unit Dose OTC Monograph Guaifenesin DM 200/20 mg/ 10 mL Guaifenesin DM 100/10 mg/ 5 mL
0904-6980-722022-07-29C16284748780-1e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4eMajor Pharmaceuticals Unit Dose OTC Monograph Guaifenesin DM 200/20 mg/ 10 mL Guaifenesin DM 100/10 mg/ 5 mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6980-72ML - Milliliter0904-69802f347743-4687-4407-8145-03a168ab2cf612019-10-07
0904-6844-70ML - Milliliter0904-68448fa8728c-7ade-4e15-a52a-eb965f8c5d4612019-10-07

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-69800904-6980-72
0904-68440904-6844-70

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
GUAIFENESIN495W7451VQACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT

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
e95ec98e-1a24-ddd9-e053-2a95a90af95e9247ea9f-3df1-ef4c-e053-2995a90aab152022-09-23WarningsExact identifier
spl set id: 9247ea9f-3df1-ef4c-e053-2995a90aab15

Reported adverse events (FAERS/openFDA)#

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