ALLFEN DM- guaifenesin and dextromethorphan hydrobromide tablet

Allfen DM by

Drug Labeling and Warnings

Allfen DM by is a Otc medication manufactured, distributed, or labeled by MCR American Pharmaceuticals, 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

Uses

temporarily relieves

• 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

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 this product unless directed by a doctor

• 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
• for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

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 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 every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
• Children 2 to under 6 years of age: Consult 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: 58605-0401-01

100 tablets

Allfen DM

Antitussive Expectorant

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

MCR American

INGREDIENTS AND APPEARANCE

ALLFEN DM 
guaifenesin and dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58605-401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 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	ALLFEN;DM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58605-401-01	100 in 1 BOTTLE, PLASTIC
2	NDC: 58605-401-02	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