Sunmark mucus relief dm tablet, extended release

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

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

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

  • do not use if printed foil under cap is broken or missing
  • store between 20-25C (68-77F)

Inactive ingredients

colloidal silicon dioxide, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Sunmark mucus relief dm tablet, extended release- Dextromethorphan hbr, guaifenesin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49348-199
Route of Administration Oral

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Copovidone k25-31 ( UNII: D9C330MD8B)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Povidone ( UNII: FZ989GH94E)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color YELLOW Size 22 mm
Shape OVAL Score 1
Imprint Code Watson;1200

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091070 USA

Labeler - Strategic Sourcing Services LLC( 116956644)

Package/label principal display panel

COMPARE TO MAXIMUM STRENGTH MUCINEX ®DM ACTIVE INGREDIENTS

maximum strength

mucus relief DM

Guaifenesin 1200 mg/Dextromethorphan

Hydrobromide 60 mg

Extended-Release Tablets

Expectorant/Cough Suppressant

Controls cough

Thins & loosens mucus

12 HOUR

Actual Size

GLUTEN FREE

14 EXTENDED-RELEASE TABLETS