Guaifenesin and dextromethorphan hbr tablet, extended release

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 Parkinsons 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 25C (68 to 77F)

Inactive ingredients


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

Questions?


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

Ingredients and appearance - Product information

Guaifenesin and dextromethorphan hbr tablet, extended release- Guaifenesin and dextromethorphan hbr

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-825
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 1200 mgin 1
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 60 mgin 1

Inactive Ingredients

Ingredient Name Code
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

Color WHITE (white to off-white) Shape OVAL
Size 22 mm Score 1
Imprint Code X;63

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA206941 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 ANALYSIS( 58602-825), MANUFACTURE( 58602-825)

Package label-principal display panel - 1200 mg/60 mg (14 tablet carton label)

NDC 58602-825-65
Primary Health
COMPARE TO Maximum Strength
Mucinex ®DM Active ingredients*


MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and
Dextromethorphan HBr
Extended-Release
Tablets 1200 mg/60 mg

EXPECTORANT AND
COUGH SUPPRESSANT

  • Controls Cough
  • Thinsand Loosens Mucus

12 Hour
14Tablets
Extended-Release Tablets