Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg) Dextromethorphan (60 mg)

Inactive Ingredients

Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: X;63 Shape: oval Color: white Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2017-03-17

Medication Information

Purpose

Cough suppressant

Expectorant

Description

( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg

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

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 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

Questions?

call 1-877-846-9949 You may also report side effects to this phone number.

Other Information

tamper evident: do not use if seal over bottle opening is broken or missing
store at 20° to 25°C (68° to 77°F)

Active Ingredients

( in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

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 (1-800-222-1222) right away.

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)

Package Label Principal Display Panel 1200 Mg/60 Mg (14 Tablet Bottle)

NDC 60000-057-65

CAREOne^®

MUCUS RELIEF DM

Guaifenesin 1200 mg / Dextromethorphan HBr 60 mg

Extended-Release Tablets

Expectorant/Cough Suppressant

Maximum Strength

Controls Cough

Thins and Loosens Mucus

14 EXTENDED-RELEASE TABLETS

Package Label Principal Display Panel 1200 Mg/60 Mg (14 Tablet Carton Label)

NDC 60000-057-65

CARE One^®

Compare to the active ingredients

in Maximum Strength Mucinex^®DM^*

MUCUS

RELIEF DM

Guaifenesin 1200 mg /

Dextromethorphan HBr 60 mg

Extended-Release Tablets

Expectorant/Cough Suppresant

Maximum Strength

Controls Cough

Thins and Loosens Mucus

12h

OUR PHARMACISTS

Rx 63

RECOMMENDED

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

Purpose

Cough suppressant

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 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

Questions?

call 1-877-846-9949 You may also report side effects to this phone number.

Other Information (Other information)

tamper evident: do not use if seal over bottle opening is broken or missing
store at 20° to 25°C (68° to 77°F)

Active Ingredients (Active ingredients)

( in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

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)

Package Label Principal Display Panel 1200 Mg/60 Mg (14 Tablet Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle))

NDC 60000-057-65

CAREOne^®

MUCUS RELIEF DM

Guaifenesin 1200 mg / Dextromethorphan HBr 60 mg

Extended-Release Tablets

Expectorant/Cough Suppressant

Maximum Strength

Controls Cough

Thins and Loosens Mucus

14 EXTENDED-RELEASE TABLETS

Package Label Principal Display Panel 1200 Mg/60 Mg (14 Tablet Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label))

NDC 60000-057-65

CARE One^®

Compare to the active ingredients

in Maximum Strength Mucinex^®DM^*

MUCUS

RELIEF DM

Guaifenesin 1200 mg /

Dextromethorphan HBr 60 mg

Extended-Release Tablets

Expectorant/Cough Suppresant

Maximum Strength

Controls Cough

Thins and Loosens Mucus

12h

OUR PHARMACISTS

Rx 63

RECOMMENDED

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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "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": "POVIDONE K90", "unii": "RDH86HJV5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K25", "unii": "K0KQV10C35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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", "Purpose": "Cough suppressant 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 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", "Questions?": "call 1-877-846-9949 You may also report side effects to this phone number.", "Other information": "tamper evident: do not use if seal over bottle opening is broken or missing store at 20° to 25°C (68° to 77°F)", "Active ingredients": "( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg", "Inactive ingredients": "colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)", "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 (1-800-222-1222) right away.", "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)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Bottle)": "NDC 60000-057-65 CAREOne ® MUCUS RELIEF DM Guaifenesin 1200 mg / Dextromethorphan HBr 60 mg Extended-Release Tablets Expectorant/Cough Suppressant Maximum Strength Controls Cough Thins and Loosens Mucus 14 EXTENDED-RELEASE TABLETS ", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)": "NDC 60000-057-65 CARE One ® Compare to the active ingredients in Maximum Strength Mucinex ® DM * MUCUS RELIEF DM Guaifenesin 1200 mg / Dextromethorphan HBr 60 mg Extended-Release Tablets Expectorant/Cough Suppresant Maximum Strength Controls Cough Thins and Loosens Mucus 12 h OUR PHARMACISTS Rx 63 RECOMMENDED 14 EXTENDED-RELEASE TABLETS "}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information