MUCUS RELIEF DMIMMEDIATE RELEASE IMMEDIATE RELEASE- dextromethorphan hbr and guaifenesin tablet 
Allegiant Health

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Drug Facts

Active ingredient (in each tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 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

  • 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)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: do not use

Other Information

  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat n do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Inactive Ingredients

croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, stearic acid

Package/Label Principal Display Panel

Mucus Relief

Mucus Relief

MUCUS RELIEF DMIMMEDIATE RELEASE  IMMEDIATE RELEASE
dextromethorphan hbr and guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-345
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize16mm
FlavorImprint Code AZ;345
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-345-0710 in 1 CARTON; Type 0: Not a Combination Product12/23/201412/31/2018
2NDC:69168-345-2620 in 1 CARTON; Type 0: Not a Combination Product12/23/201412/31/2018
3NDC:69168-345-98200 in 1 BOTTLE; Type 0: Not a Combination Product12/23/201412/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/23/201412/31/2018
Labeler - Allegiant Health (079501930)

Revised: 11/2017
Document Id: 3a947952-e11b-49fc-99ad-64519b94648a
Set id: e3774f74-ee88-48f9-9745-012ab7b8a4f5
Version: 9
Effective Time: 20171109
 
Allegiant Health