Guaifenesin And Dextromethorphan Hydrobromide

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg) Dextromethorphan (60 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: xeunciM;1200; Shape: oval Color: white Size: 22 mm Score: 1

Marketing Status

NDA Active Since 2017-09-05

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

Directions

•
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 tablet every 12 hours; not more than 2 tablets in 24 hours
•
children under 12 years of age: do not use

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.

Other Information

•
Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
•
store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions Or Comments?

1-800-632-6900

You may also report side effects to this phone number.

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

COMPARE TO the active ingredients of

MAXIMUM STRENGTH MUCINEX^® DM *See back panel

NDC 30142-706-14

Kroger_®

OUR PHARMACIST RECOMMENDED

Maximum Strength

Mucus Relief

ER DM - Max

Guaifenesin 1200 mg &

Dextromethorphan HBr 60 mg

Extended-Release

Tablets

EXPECTORANT &

COUGH SUPPRESSANT

12

HOUR

Controls Cough
Thins & Loosens Mucus
Immediate & Extended Release

actual

size

14 EXTENDED-RELEASE

TABLETS

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

Directions

•
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 tablet every 12 hours; not more than 2 tablets in 24 hours
•
children under 12 years of age: do not use

Do Not Use (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.

Other Information (Other information)

•
Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
•
store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions Or Comments? (Questions or comments?)

1-800-632-6900

You may also report side effects to this phone number.

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)

COMPARE TO the active ingredients of

MAXIMUM STRENGTH MUCINEX^® DM *See back panel

NDC 30142-706-14

Kroger_®

OUR PHARMACIST RECOMMENDED

Maximum Strength

Mucus Relief

ER DM - Max

Guaifenesin 1200 mg &

Dextromethorphan HBr 60 mg

Extended-Release

Tablets

EXPECTORANT &

COUGH SUPPRESSANT

12

HOUR

Controls Cough
Thins & Loosens Mucus
Immediate & Extended Release

actual

size

14 EXTENDED-RELEASE

TABLETS

Advanced Ingredient Data

[{"name": "Guaifenesin", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "Directions": "• 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 tablet every 12 hours; not more than 2 tablets in 24 hours • children under 12 years of age: do not use", "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.", "Other information": "• Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. • store between 20-25°C (68-77°F)", "Inactive ingredients": "carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF", "Questions or comments?": "1-800-632-6900 You may also report side effects to this phone number.", "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": "COMPARE TO the active ingredients of MAXIMUM STRENGTH MUCINEX ® DM *See back panel NDC 30142-706-14 Kroger ® OUR PHARMACIST RECOMMENDED Maximum Strength Mucus Relief ER DM - Max Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets EXPECTORANT & COUGH SUPPRESSANT 12 HOUR Controls Cough Thins & Loosens Mucus Immediate & Extended Release actual size 14 EXTENDED-RELEASE TABLETS"}

Guaifenesin And Dextromethorphan Hydrobromide

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information