MUCUS DM EXTENDED RELEASE- guaifenesin, dextromethorphan hydrobromide tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
CVS Pharmacy
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant Expectorant
Authorization status:
Abbreviated New Drug Application
Authorization number:
69842-963-01, 69842-963-49

MUCUS DM EXTENDED RELEASE- guaifenesin, dextromethorphan hydrobromide tablet,

extended release

CVS Pharmacy

----------

CVS Pharmacy, Inc. Mucus DM Extended Release Drug Facts

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 600 mg

Purpos es

Cough suppressant

Expectorant

Us es

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

temporarily relieves:

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled

irritants

the intensity of coughing

the impulse to cough to help you get to sleep

for children under 12 years of age

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.

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

cough accompanied by too much phlegm (mucus)

do not use more than directed

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

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. (1-800-222-1222)

Directions

Other information

Inactive ingredients

carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose,

magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Mucinex

Mucus DM Extended Release

12 HOUR

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE EXTENDED-RELEASE

TABLETS, 600 mg/30 mg

EXPECTORANT/COUGH SUPPRESSANT

Controls cough

Thin & loosens mucus

Actual Size

20 EXTENDED-RELEASE TABLETS

These could be signs of a serious illness.

do not crush, chew, or break tablet

take with a full glass of water

this product can be administered without regard for timing of meals

adults and children 12 years and older:

1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours

children under 12 years of age: do not use

each tablet contains: magnesium 15 mg

do not use if printed foil under cap is broken or missing

store between 20-25°C (68-77°F)

MUCUS DM EXTENDED RELEASE

guaifenesin, dextromethorphan hydrobromide tablet, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-9 6 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

30 mg

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

6 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER HO MO PO LYMER TYPE B ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: HHT0 1ZNK31)

CVS Pharmacy

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM HYDRO XIDE (UNII: NBZ3QY0 0 4S)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

OVAL

S iz e

16 mm

Flavor

Imprint Code

L219 ;6 0 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-9 6 3-0 1

1 in 1 CARTON

0 9 /13/20 19

1

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 9 8 42-9 6 3-49

1 in 1 CARTON

0 9 /13/20 19

2

40 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 76 0 2

0 9 /13/20 19

Labeler -

CVS Pharmacy (062312574)

Revised: 9/2019

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