MAXIPHEN DM- guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet

Maxiphen DM by

Drug Labeling and Warnings

Maxiphen DM by is a Otc medication manufactured, distributed, or labeled by MCR American Pharmaceuticals, Inc., TG United Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

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

• Do not exceed recommended dosage.

• 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

• 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

• 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

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

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur

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

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

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

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Question? Comments?

Call 1-352-754-8587

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

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

INGREDIENTS AND APPEARANCE

MAXIPHEN DM 
guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58605-423
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	400 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	20 mg

Inactive Ingredients
Ingredient Name	Strength
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL (Capsule Shaped)	Size	16mm
Flavor		Imprint Code	MAXIPHEN;DM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58605-423-01	100 in 1 BOTTLE, PLASTIC
2	NDC: 58605-423-02	20 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/31/2008

Labeler - MCR American Pharmaceuticals, Inc. (783383011)

Establishment
Name	Address	ID/FEI	Business Operations
MCR American Pharmaceuticals, Inc.		783383011	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
TG United Inc		172837085	MANUFACTURE