FDA.reportPublic FDA data

Capmist DM Tablets

Manufacturer
Capital Pharmaceutical, LLC
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:19:23

Label at a glance#

ProductCapmist DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure14 sections

Indications and 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

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Dextromethorphan HBr 15mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Guaifenesin 400mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Pseudoephedrine HCl 60mg

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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:

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.
Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of age:Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

FD&C Blue #1, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 29978-601-90
CAPMIST DM Tablets
Cough Suppressant ● Expectorant
Nasal Decongestant
90 tablets

PRINCIPAL DISPLAY PANEL NDC 29978-601-90 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 90 tabletsPRINCIPAL DISPLAY PANEL NDC 29978-601-90 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 90 tablets

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 29978-601-30
CAPMIST DM Tablets
Cough Suppressant ● Expectorant
Nasal Decongestant
3 0 samples

PRINCIPAL DISPLAY PANEL NDC 29978-601-30 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 30 samplesPRINCIPAL DISPLAY PANEL NDC 29978-601-30 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 30 samples

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1426660dextromethorphan HBr 15 MG / guaiFENesin 400 MG / pseudoephedrine HCl 60 MG Oral TabletPSN9
1426660dextromethorphan hydrobromide 15 MG / guaifenesin 400 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29978-601-302025-12-03C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets
29978-601-902025-12-03C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets
29978-601-302025-07-29C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets
29978-601-902025-07-29C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets
29978-601-302020-03-12C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets
29978-601-902020-03-12C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets
29978-601-302020-01-31C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets
29978-601-902020-01-31C16284748780-19d75b9d0-fa96-f424-e053-dadaa90a57ceCapmist DM Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29978-601-30Capmist DM2 in 1 BOXTABLET29
29978-601-30Capmist DM15 in 1 BLISTER PACKTABLET159
29978-601-90Capmist DM90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29978-601-90EA - Each29978-601257bd348-59df-4765-a2b5-f60c025e81f212013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
GUAIFENESINACTIVE INGREDIENT495W7451VQ2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
GUAIFENESINACTIVE MOIETY495W7451VQ2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A22

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29978-60129978-601-30, 29978-601-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Capmist DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECapital Pharmaceutical, LLC63733ac3-859e-4a8e-8717-d852bd3034082025-12-03WarningsExact identifier
ndc (package): 29978-601-90
ndc (package): 29978-601-30
ndc (product): 29978-601
ndc11 (package): 29978060130
ndc11 (package): 29978060190
spl id: 45134129-e509-ebf0-e063-6294a90a03cd
spl set id: 63733ac3-859e-4a8e-8717-d852bd303408

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.