CAPMIST by Capital Pharmaceutical / Pernix Manufacturing, LLC / Pernix Manufacturing, LLC dba Great Southern Laboratories CAPMIST DM TABLETS

CAPMIST by

Drug Labeling and Warnings

CAPMIST by is a Otc medication manufactured, distributed, or labeled by Capital Pharmaceutical, Pernix Manufacturing, LLC, Pernix Manufacturing, LLC dba Great Southern Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CAPMIST DM- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet 
Capital Pharmaceutical

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.

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CAPMIST DM TABLETS

Drug Facts

Active ingredients (in each tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 400 mg

Pseudoephedrine HCl 30 mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Description

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

Uses

Temporarily 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 information

Store 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 ingredients

colloidal 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 Packaging

The 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 TABLETS Packaging
CAPMIST DM TABLETS Packaging
CAPMIST DM TABLETS Packaging

CAPMIST  DM
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29978-606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize19mm
FlavorImprint Code CAP;DM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 29978-606-9090 in 1 BOTTLE; Type 0: Not a Combination Product07/27/201103/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/27/201103/01/2020
Labeler - Capital Pharmaceutical (831545541)

Revised: 3/2020
 
Capital Pharmaceutical