Duract™ Max Strength COUGH

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

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 older1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours
Children under 12DO NOT USE

Other information

Inactive ingredients

Acetylated Monoglyceride, Citric Acid, Crospovidone, FD&C Red #40 Aluminum Lake, Magnesium Stearate, Maltodextrin, Mannitol, Microcrystalline Cellulose, Modified Food Starch, Natural & Artificial Flavors, 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 62750-042-10

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

Cherry flavor

12 QuikMelt Tablets

PRINCIPAL DISPLAY PANEL - 12 Tablet Carton

DURACT   MAX STRENGTH COUGH
dextromethorphan hydrobromide tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-042
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide30 mg
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Crospovidone 
FD&C Red No. 40 
Aluminum Oxide 
Magnesium Stearate 
Maltodextrin 
Mannitol 
Cellulose, Microcrystalline 
Starch, Corn 
Polysorbate 80 
Silicon Dioxide 
Sodium Polystyrene Sulfonate 
Sucralose 
Talc 
Product Characteristics
ColorPINK (Light Pink) Score no score
ShapeROUND (Cup Shaped) Size14mm
FlavorCHERRYImprint Code CP226
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:62750-042-101 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
112 TABLET, ORALLY DISINTEGRATING ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (62750-042-10)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2011

Labeler - Matrixx Initiatives, Inc. (790037253)
Establishment
NameAddressID/FEIOperations
Capricorn Pharma Inc.041704524MANUFACTURE

Revised: 08/2011 Matrixx Initiatives, Inc.