Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Silicon Dioxide Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Talc

Identifiers & Packaging

Pill Appearance

Imprint: AN036 Shape: oval Color: blue Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2018-09-30

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg

.

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L5769245-10225 / L5769245-20225

Product of India

Rev. 08/24

M-58

Re-order No. 701018

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Directions

•
do not crush, chew, or break tablet
•
take with a full glass of water
•
this product can be administered without regard for the timing of meals
•
adults and children 12 years of age and over: 1 or 2 tablet every 12 hours. Do not exceed 4 tablets in 24 hours.
•
children under 12 years of age: do not use

Do Not Use

for children under 12 years of age.

Other Information

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

Inactive Ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

NDC 55154-4153-0

MUCUS RELIEF ER

GUAIFENESIN 600 MG

EXPECTORANT

10 EXTENDED-RELEASE TABLETS

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).

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)

Active Ingredient (in Each Extended Release tablet)

Guaifenesin 600 mg

Structured Label Content

.

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L5769245-10225 / L5769245-20225

Product of India

Rev. 08/24

M-58

Re-order No. 701018

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Purpose

Expectorant

Directions

•
do not crush, chew, or break tablet
•
take with a full glass of water
•
this product can be administered without regard for the timing of meals
•
adults and children 12 years of age and over: 1 or 2 tablet every 12 hours. Do not exceed 4 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.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

NDC 55154-4153-0

MUCUS RELIEF ER

GUAIFENESIN 600 MG

EXPECTORANT

10 EXTENDED-RELEASE TABLETS

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

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)

Active Ingredient (in Each Extended Release tablet) (Active ingredient (in each extended-release tablet))

Guaifenesin 600 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "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, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{".": "*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®. Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Distributed By: Cardinal Health Dublin, OH 43017 L5769245-10225 / L5769245-20225 Product of India Rev. 08/24 M-58 Re-order No. 701018", "Uses": "Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.", "Purpose": "Expectorant", "Directions": "• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 or 2 tablet every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use ", "Do not use": "for children under 12 years of age.", "Other information": "• store between 20º to 25ºC (68º to 77ºF)", "Inactive ingredients": "carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "NDC 55154-4153-0 MUCUS RELIEF ER GUAIFENESIN 600 MG EXPECTORANT 10 EXTENDED-RELEASE TABLETS", "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).", "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)", "Active ingredient (in each extended-release tablet)": "Guaifenesin 600 mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information