Maxiphen DM

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each immediate-release tablet)	Purpose
Dextromethorphan HBr 20 mg	Antitussive
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

• cough due to minor throat or bronchial irritation associated with a cold
• cough impulses without narcotics
• helps loosen phlegm and thin bronchial secretions to make coughs more productive
• nasal congestion
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

• Do not exceed recommended dosage.

OTC - ASK DOCTOR SECTION

• a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor

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 SECTION

• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you are taking sedatives or tranquilizers

Stop use and ask a doctor if

OTC - STOP USE SECTION

• nervousness, dizziness or sleeplessness 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 accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Question? Comments?

OTC - QUESTIONS SECTION

Call 1-352-754-8587

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58605-0423-01

100 tablets

Maxiphen DM

Antitussive • Expectorant • Nasal Decongestant

Each immediate-release tablet contains:
Dextromethorphan HBr	20 mg
Guaifenesin	400 mg
Phenylephrine HCl	10 mg

This bottle is not be dispensed to consumer.

Dispense in a tight light-resistant container with
a child-resistant cap.

Store at 59°-86°F (15°-30°C) [see USP
Controlled Room Temperature]

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

MCR American

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• Maxiphen DM
• Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
• Guaifenesin
• Phenylephrine Hydrochloride
• Phenylephrine
• Dextromethorphan Hydrobromide
• Dextromethorphan
• Magnesium Stearate
• Cellulose, Microcrystalline
• Sodium Starch Glycolate Type A Potato

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 67 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

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