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Guaifenesin and Dextromethorphan HBr

Medically reviewed on May 8, 2018

Dosage form: tablet, extended release
Ingredients: GUAIFENESIN 1200mg, DEXTROMETHORPHAN HYDROBROMIDE 60mg
Labeler: Aurohealth LLC
NDC Code: 58602-715

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 1-855-274-4122  You may also report side effects to this phone number.

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

NDC 58602-715-05
MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

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

Compare to the active ingredients of
Maximum Strength Mucinex® DM*
NDC 58602-715-05
Mucus Relief DM
MAXIMUM STRENGTH
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
14 Extended-release Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

Comparative to the active ingredients of
Maximum Strength Mucinex® DM*
NDC 58602-715-70
MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND
COUGH SUPPRESSANT
12 HOUR
Controls Cough
Thins and Loosens Mucus
28 (4 x7)
Extended-release Tablets
AUROHEALTH

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-715
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POVIDONE K90 
POVIDONE K25 
STARCH, CORN 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeX;63
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-715-051 BOTTLE in 1 CARTON
114 TABLET, EXTENDED RELEASE in 1 BOTTLE
2NDC:58602-715-571 BOTTLE in 1 CARTON
228 TABLET, EXTENDED RELEASE in 1 BOTTLE
3NDC:58602-715-091 BOTTLE in 1 CARTON
330 TABLET, EXTENDED RELEASE in 1 BOTTLE
4NDC:58602-715-681 BOTTLE in 1 CARTON
438 TABLET, EXTENDED RELEASE in 1 BOTTLE
5NDC:58602-715-601 BOTTLE in 1 CARTON
542 TABLET, EXTENDED RELEASE in 1 BOTTLE
6NDC:58602-715-691 BOTTLE in 1 CARTON
644 TABLET, EXTENDED RELEASE in 1 BOTTLE
7NDC:58602-715-151 BOTTLE in 1 CARTON
760 TABLET, EXTENDED RELEASE in 1 BOTTLE
8NDC:58602-715-704 BLISTER PACK in 1 CARTON
87 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
9NDC:58602-715-066 BLISTER PACK in 1 CARTON
97 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
10NDC:58602-715-652 BLISTER PACK in 1 CARTON
107 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
11NDC:58602-715-106 BLISTER PACK in 1 CARTON
118 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694103/17/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(58602-715), MANUFACTURE(58602-715)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited918917626API MANUFACTURE(58602-715)

 
Aurohealth LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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