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.

----------

Duract
Max Strength
COUGH

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 older1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours
Children under 12DO 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide30 mg
Inactive Ingredients
Ingredient NameStrength
Diacetylated Monoglycerides (UNII: 5Z17386USF)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FD&C Blue No. 2 (UNII: L06K8R7DQK)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
Aluminum Oxide (UNII: LMI26O6933)  
Acacia (UNII: 5C5403N26O)  
Magnesium Stearate (UNII: 70097M6I30)  
Mannitol (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Silicon dioxide (UNII: ETJ7Z6XBU4)  
Sodium Polystyrene Sulfonate (UNII: 1699G8679Z)  
Sucralose (UNII: 96K6UQ3ZD4)  
Talc (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorGREEN (Light Green) Scoreno score
ShapeROUND (cup shaped) Size14mm
FlavorMINTImprint Code CP227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62750-041-102 in 1 CARTON08/01/201108/15/2017
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/201108/15/2017
Labeler - Matrixx Initiatives, Inc. (790037253)

Revised: 8/2017
 
Matrixx Initiatives, Inc.