MUCUS RELIEF DM- guaifenesin, dextromethorphan hbr tablet

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

Buy It Now

Active ingredient:
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Available from:
WinCo Foods, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough Suppressant Expectorant - 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 - 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
67091-344-20

MUCUS RELIEF DM- guaifenesin, dextromethorphan hbr tablet

WinCo Foods, LLC

----------

Drug Facts

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 600 mg

Purpos e

Cough Suppressant

Expectorant

Us es

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

Warnings

Do not use

for children under12 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.

Ask a doctor before use if you have

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

cough accompanied by too much phlegm (mucus)

When using this product,

do not use more than directed.

Stop use and ask a doctor if

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

could be signs of a serious illness.

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

do not crush, chew, or break tablet

take with a full glass of water

this product can be administered without regards for timing of meals

adults and children 12 years of age and older: 1 or 2 tablet every 12 hours; not more than 4 tablets in

24 hours

children under 12 years of age: do not use

Other information

store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose

monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

Call 1-800-824-1706 Monday - Friday 9AM - 4PM MST

Principal Display Panel

Compare to active ingredients in MUCINEX® DM

Mucus Relief DM

EXPECTORANT & COUGH SUPPRESSANT

DEXTROMETHORPHAN HBr 30 mg/COUGH SUPPRESSANT

GUAIFENESIN 600 mg / EXPECTORANT

Controls Cough for 12 Hours

Thins & Loosen Mucus

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of MUCINEX®

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

Package Label

WINCO FOODS Mucus Relief DM

MUCUS RELIEF DM

guaifenesin, dextromethorphan hbr tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 70 9 1-344

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

GUAIFENESIN

6 0 0 mg

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

30 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

WinCo Foods, LLC

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

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

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

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

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

OVAL

S iz e

16 mm

Flavor

Imprint Code

AN0 38

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 70 9 1-344-20

20 in 1 CARTON

0 9 /0 1/20 19

1

1 in 1 BLISTER PACK; 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 9 6 9 2

0 9 /0 1/20 19

Labeler -

WinCo Foods, LLC (056098817)

Revised: 2/2020

Similar products

Search alerts related to this product

View documents history

Share this information