MAXIMUM STRENGTH MUCUS-DM - guaifenesin and dextromethorphan hbr tablet, extended release 
SUPERVALU INC

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Drug Facts

Active ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purpose

Cough suppressant
Expectorant

Uses


  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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

  • for children under 12 years of age
  • 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


  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product


  • do not use more than directed

Stop use and ask a doctor if


  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 (1-800-222-1222) right away.

Directions


  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Other information


  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions?


call 1-877-932-7948  You may also report side effects to this phone number.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

NDC 41163-985-65

compare to
Maximum Strength
Mucinex® DM  
active ingredients*
  
EQUALINE®           
 
maximum strength
mucus-DM
guaifenesin 1200 mg/
dextromethorphan HBr 60 mg
extended-release tablets
(expectorant/cough suppressant)

12 hour
• controls cough
• thins and loosens mucus

14 tablets  

figure1   

MAXIMUM STRENGTH MUCUS-DM 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-985
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
POVIDONE K25 (UNII: K0KQV10C35)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code X;63
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-985-652 in 1 CARTON03/17/201711/30/2020
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694103/17/201711/30/2020
Labeler - SUPERVALU INC (006961411)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(41163-985) , MANUFACTURE(41163-985)

Revised: 10/2022
 
SUPERVALU INC