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

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 15mg

Purpose

Cough Suppressant

Active ingredients

(in each tablet)

Guaifenesin 400mg

Purpose

Expectorant

Active ingredients

(in each tablet)

Pseudoephedrine HCl 60mg

Purpose

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

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

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

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 samples

CAPMIST DM
dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:29978-601
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	green (light green)	Score	2 pieces
Shape	CAPSULE (oblong)	Size	19mm
Flavor		Imprint Code	CAP;DM
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:29978-601-30	2 in 1 BOX	06/20/2013
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:29978-601-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/20/2013

Labeler - Capital Pharmaceutical, LLC (831545541)

Name	Address	ID/FEI	Business Operations
Establishment
TG United, Inc.		172837085	manufacture(29978-601)

Revised: 3/2020

Document Id: a0acda2e-9077-bf35-e053-2995a90a8092

Set id: 63733ac3-859e-4a8e-8717-d852bd303408

Version: 3

Effective Time: 20200312

Capital Pharmaceutical, LLC