DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

Manufacturer
Monarch PCM, LLC.
Effective date
2019-08-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:14:12

Label at a glance#

ProductDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: ○ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ○ the intensity of coughing ○ the impulse to cough to help you get to sleep ○ nasal congestion due to a cold

Dosage and administration

do not take more than 6 doses in any 24-hour period use enclosed dosage cup or tablespoon (TBSP) dose as follows or as directed by a doctor Adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) iper 24 hours Children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours Children under 6 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dextromethorphan HBr

Guaifenesin
Phenylephrine HCl

70154-112-08

8 fl. Oz. (240 mL)

Active ingredients (in each 15 mL (TBSP))

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 18 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:

○ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

○ the intensity of coughing

○ the impulse to cough to help you get to sleep

○ nasal congestion due to a cold

Warnings

WARNINGS SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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

■ nervousness, dizziness, or sleeplessness occurs
■ symptoms do not improve within 7 days, tend to recur, or
are accompanied by a fever, rash or persistent headache.
A persistent cough may be a sign of a serious condition.
■ new symptoms occur

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosage cup or tablespoon (TBSP)
  • dose as follows or as directed by a doctor
Adults and children 12 years of age and over:15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) iper 24 hours
Children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours
Children under 6 years of age:Consult a doctor.

Other information

OTHER SAFETY INFORMATION

■ this packaging is child-resistant.
■ each 15 mL (1 TBSP) contains:Sodium 8 mg
■ store at room temperature 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, glycerin, masking agent, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-844-696-6627

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70154-112-08

Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Cough Suppressant • Expectorant • Nasal Decongestan

8 fl. oz. (240 mL)

PDP1PDP1

PDP2PDP2

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70154-11270154-112-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a473b626-a3e5-7b7c-e053-2995a90ac57490960006-4946-0e18-e053-2a95a90a42ac2020-04-29WarningsExact identifier
spl set id: 90960006-4946-0e18-e053-2a95a90a42ac

Reported adverse events (FAERS/openFDA)#

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