Sunmark mucus relief tablet, extended release

Active ingredient(in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Use(s)

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

Warning

.

Do not use

forchildren under 12 years of age

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • coughlasts 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,

aska health professional before use.

Keep out of reach of children

Incase of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • do notcrush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours.
  • Do not exceed4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

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

Inactive ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Questions?

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number.

Ingredients and appearance - Product information

Sunmark mucus relief tablet, extended release- Guaifenesin

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 70677-0055
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 600 mgin 1

Inactive Ingredients

Ingredient Name Code
Carbomer homopolymer, unspecified type ( UNII: 0A5MM307FC)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Povidone ( UNII: FZ989GH94E)

Product Characteristics

Color WHITE Shape CAPSULE
Size 22 mm Score 1
Imprint Code G233

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA209215 USA

Labeler - Strategic Sourcing Services LLC( 116956644)

Principal display panel

sunmark
COMPARE TO THE ACTIVE INGREDIENT INMUCINEX ®EXTENDED RELEASE 600 MG TABLETS

NDC 70677-0055-1

12 hour
mucus relief

Guaifenesin Extended-ReleaseTablets 600 mg

Expectorant

Relieves chest congestion

Thins and Loosens Mucus

40 Extended-Release Tablets