280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets

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

280R-Timely-200s-label 280RLABEL Enter section text here

MUCOSA DM
guaifenesin dextromethorphan tablet

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-280-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
2	NDC:49483-280-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/17/2018
3	NDC:49483-280-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2023

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

Labeler - TIME CAP LABORATORIES, INC. (037052099)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

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