OTC Medication Information: MUCOSA DM

MUCOSA DM- guaifenesin and dextromethorphan hydrobromide tablet
TIME CAP LABORATORIES, INC.

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.

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough suppressant

Expectorant

Uses
• helps loosen phlegm (mucus)
• helps thin bronchial secretions to make coughs more productive
• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Warnings

Do not use 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

• cough accompanied by excessive phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

• do not exceed recommended dosage
• do not use for more than 7 days

Stop use and ask a doctor if

• cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a healthcare professional before use

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
• children under 12 years of age: do not use

Other information

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• keep in a dry place and do not expose to excessive heat

Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-877-290-4008

MUCOSA DM guaifenesin dextromethorphan tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-280 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID

Product Characteristics Color white Score no score Shape ROUND Size 16mm Flavor Imprint Code TCL280 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49483-280-06 60 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:49483-280-00 100000 TABLET in 1 CARTON None 3 NDC:49483-280-20 200 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/17/2012

Labeler — TIME CAP LABORATORIES, INC. (037052099)

Registrant — TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture (49483-280)

Revised: 09/2023 TIME CAP LABORATORIES, INC.