Active Ingredients
(in each tablet)
Dextromethorphan HBr 15mg
(in each tablet)
Guaifenesin 400mg
(in each tablet)
Pseudoephedrine HCl 60mg
Capmist Dm Tablet
FDA Label NDC 29978-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Capital Pharmaceutical, Llc for the product Capmist Dm (NDC 29978-601). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, stop use and ask a doctor if:, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
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
| 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
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
FD&C Blue #1, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.
Principal Display Panel
NDC 29978-601-90
CAPMIST DM Tablets
Cough Suppressant ● Expectorant
Nasal Decongestant
90 tablets
Principal Display Panelndc 29978-601-90capmist Dm Tabletscough Suppressant ● Expectorantnasal Decongestant90 Tablets (Capmist Dm Tablets 01)
NDC 29978-601-30
CAPMIST DM Tablets
Cough Suppressant ● Expectorant
Nasal Decongestant
30 samples
Principal Display Panelndc 29978-601-30capmist Dm Tabletscough Suppressant ● Expectorantnasal Decongestant30 Samples (Capmist Dm Tablets 02)
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