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CAPMIST DM by Capital Pharmaceutical

Dosage form: tablet
Ingredients: Dextromethorphan Hydrobromide 30mg, Guaifenesin 400mg, Pseudoephedrine Hydrochloride 30mg
Labeler: Capital Pharmaceutical
NDC Code: 29978-606

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CAPMIST DM TABLETS

Drug Facts Active ingredients
(in each tablet)
Dextromethorphan HBr 30 mg
Guaifenesin 400 mg
Pseudoephedrine HCl 30 mg

PurposeCough Suppressant
Expectorant
Nasal Decongestant

DescriptionCapmist DM is a green, oblong, capsule shaped, scored tablet, imprinted CAP DM on one side and blank on the other.

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings Do not exceed recommended dosage.

Do not use this product
  • 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
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlargement of the prostate gland

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

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.

Directions Do not exceed recommended dosage.
Adults and children
12 years of age
and over:
1 tablet every 6 hours, not
to exceed 4 tablets in 24
hours.
Children 12 years
of age and younger:
Consult a doctor.


Other informationStore at 15° - 30°C (59° - 86°F).

Capmist DM is a light green, oblong, capsule shaped, scored tablet, debossed "CAP" bisect "DM" on one side
and blank on the other.

Contains color additives including FD&C Yellow No. 5 (tartrazine).

Supplied in a tight, light-resistant container with a child-resistant cap.

Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, hypromellose, maltodextrin, povidone, slicified microcrystalline cellulose, and stearic acid.

Questions? Comments?Serious side effects may be reported to this
number.  Call 1 (614) 638-4622.

Manufactured for:                                                       
Capital Pharma                                           
Powell, OH  43065 

Manufactured by:
Great Southern Laboratories
Houston, TX  77099                                                

Rev. 02/12            

Product PackagingThe packaging below represents the labeling currently used:

Principal display panel and side panel for 90 tablets labeling:

NDC 29978-606-90                 

CAPMIST DM
TABLETS

COUGH SUPPRESSANT · EXPECTORANT
NASAL DECONGESTANT

Each tablet contains:
Dextromethorphan HBr.........................30 mg
Guaifenesin.......................................400 mg
Pseudoephedrine HCl...........................30 mg

CAPITAL
pharmaceutical              90 tablets

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Distributed by:  Capital Pharma, Powell, OH  43065
1 (614) 638-4622                      Rev. 02/12







CAPMIST  DM
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29978-606
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide30 mg
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium 
Hypromelloses 
Silicon Dioxide 
Cellulose, Microcrystalline  
Stearic Acid 
Maltodextrin 
Povidones 
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize19mm
FlavorImprint CodeCAP;DM
Contains    
Packaging
#Item CodePackage Description
1NDC:29978-606-9090 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/27/2011
Labeler - Capital Pharmaceutical (831545541)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIOperations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(29978-606)

Revised: 02/2013
 
Capital Pharmaceutical

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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