Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:25:44

Label at a glance#

ProductDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours. Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours. Children under 6 years of age: Consult a doctor.

Storage and handling

Store at 15°-30°C (59°-86°F) Supplied in a tight, light-resistant container with a child-resistant cap. Dextromethorphan HBr; Guaifenisan; Phenylephrine HCl tablets are orange, oblong, capsule shaped, scored tablets, debossed "WP" bisect "198" on one side and plain on the other.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Dextromethorphan HBr 17.5mgCough Suppressant
Guaifenesin 385mgExpectorant
Phenylephrine HCl 10mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

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 SECTION

  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlargement of the prostate gland

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
  • A persistent cough may be a sign of a serious condition.
  • new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.
Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
Children under 6 years of age:Consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30°C (59°-86°F)

Supplied in a tight, light-resistant container with a child-resistant cap. Dextromethorphan HBr; Guaifenisan; Phenylephrine HCl tablets are orange, oblong, capsule shaped, scored tablets, debossed "WP" bisect "198" on one side and plain on the other.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Yellow #6, D&C Yellow #10, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-198-90

Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Cough Suppressant • Expectorant
Nasal Decongestant

Each tablet contains:

Dextromethorphan HBr
17.5 mg

Guaifenesin
385 mg

Phenylephrine HCl
10 mg

90 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-198-90EA - Each69367-198d35a0ad1-c290-486f-bbaa-c97830ee2c6412019-04-11

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
69367-19869367-198-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
5eda0c05-7c22-4189-8594-7e5d39ac4c175630060f-553a-442e-bc1e-8fa1249930232022-12-12WarningsExact identifier
spl id: 5eda0c05-7c22-4189-8594-7e5d39ac4c17
spl set id: 5630060f-553a-442e-bc1e-8fa124993023

Reported adverse events (FAERS/openFDA)#

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