DURACT MAX STRENGTH COUGH - dextromethorphan hydrobromide tablet, orally disintegrating
Matrixx Initiatives, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each tablet)

Dextromethorphan HBr 30mg

Purpose

Cough Suppressant

Uses

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

Warnings

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

Cough accompanied by excessive phlegm (mucus).
Persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Stop use and ask a doctor if

Cough persists for more than 7 days, tends to reoccur or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older	1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours
Children under 12	DO NOT USE

Other information

Each tablet contains: Sodium 7 mg.
Store at room temperature 15°C-30°C (59°F-86°F).
See bottom panel for Lot number and expiration date.

Inactive ingredients

Acetylated Monoglyceride, Citric Acid, Crospovidone, FD&C Blue #2 Aluminum Lake, FD&C Yellow #5 Aluminum Lake (Tartrazine), Gum Arabic, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Natural Flavor, Polysorbate 80, Silicondioxide, Sodium Polystyrene Sulfonate, Sucralose, Talc.

Questions or comments?

Call toll free 1-877-942-2626

Distributed by Matrixx Initiatives, Inc., Scottsdale, Arizona 85255

PRINCIPAL DISPLAY PANEL - 12 Tablet Carton

New!

NDC 62750-041-10

Duract™

Max Strength
COUGH

Dextromethorphan HBr 30mg Cough Suppressant

✔: Relieves Cough for Up to 8 Hours
✔: Non-Drowsy Formula
✔: Pleasant Refreshing Taste

QuikMelt
Melts in your mouth!

Up to
8
FULL
HOURS

Cool Mint flavor

12 QuikMelt Tablets

PRINCIPAL DISPLAY PANEL - 12 Tablet Carton

DURACT MAX STRENGTH COUGH
dextromethorphan hydrobromide tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62750-041
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (Dextromethorphan)	Dextromethorphan Hydrobromide	30 mg

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate
Crospovidone
FD&C Blue No. 2
FD&C Yellow No. 5
Aluminum Oxide
Acacia
Magnesium Stearate
Mannitol
Cellulose, Microcrystalline
Polysorbate 80
Silicon dioxide
Sodium Polystyrene Sulfonate
Sucralose
Talc

Product Characteristics
Color	GREEN (Light Green)	Score	no score
Shape	ROUND (cup shaped)	Size	14mm
Flavor	MINT	Imprint Code	CP227
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:62750-041-10	1 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		12 TABLET, ORALLY DISINTEGRATING ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (62750-041-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/01/2011

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Operations
Capricorn Pharma Inc.		041704524	MANUFACTURE

Revised: 08/2011 Matrixx Initiatives, Inc.