Guaifenesin And Dextromethorphan Hbr

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg) Dextromethorphan (60 mg)

Inactive Ingredients

Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Silicon Dioxide Maltodextrin Povidone K30 Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 053 Shape: oval Color: white Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2021-07-01

Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 53414-9

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

Section 55105-1

Active ingredients (in each extended-release tablet)	Purposes
Dextromethorphan HBr 60 mg	Cough suppressant
Guaifenesin 1200 mg	Expectorant

Warnings

Do not use

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.

Directions

do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
children under 12 years of age: do not use

Other Information

Store between 68-77°F (20-25°C)

Inactive Ingredients

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

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.

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)

Principal Display Panel 14 Tablet Blister Pack Carton

NDC 41415-999-14

12-HOUR MAXIMUM STRENGTH

mucusreliefDM

GUAIFENESIN 1200 mg &

DEXTROMETHORPHAN HBr 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT &

COUGH SUPPRESSANT

12 Hour

Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release

14 EXTENDED-RELEASE

TABLETS

^†Compare to the active

ingredients of Mucinex^® DM

Maximum Strength

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each extended-release tablet)	Purposes
Dextromethorphan HBr 60 mg	Cough suppressant
Guaifenesin 1200 mg	Expectorant

Warnings

Do not use

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.

Directions

do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
children under 12 years of age: do not use

Other Information (Other information)

Store between 68-77°F (20-25°C)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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)

Principal Display Panel 14 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton)

NDC 41415-999-14

12-HOUR MAXIMUM STRENGTH

mucusreliefDM

GUAIFENESIN 1200 mg &

DEXTROMETHORPHAN HBr 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT &

COUGH SUPPRESSANT

12 Hour

Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release

14 EXTENDED-RELEASE

TABLETS

^†Compare to the active

ingredients of Mucinex^® DM

Maximum Strength

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "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", "42229-5": "Drug Facts", "50565-1": "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).", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each extended-release tablet) Purposes Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1200 mg Expectorant", "Warnings": "Do not use 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.", "Directions": "do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use", "Other information": "Store between 68-77°F (20-25°C)", "Inactive ingredients": "carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid", "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.", "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)", "PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton": "NDC 41415-999-14 12-HOUR MAXIMUM STRENGTH mucusreliefDM GUAIFENESIN 1200 mg & DEXTROMETHORPHAN HBr 60 mg EXTENDED-RELEASE TABLETS EXPECTORANT & COUGH SUPPRESSANT 12 Hour Controls Cough Thins and Loosens Mucus Immediate and Extended Release 14 EXTENDED-RELEASE TABLETS † Compare to the active ingredients of Mucinex ® DM Maximum Strength"}

Guaifenesin And Dextromethorphan Hbr

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information