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

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

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

Description

Guaifenesin 600 mg

Principal Display Panel

NDC 55154-4153-0

MUCUS RELIEF ER

GUAIFENESIN 600 MG

EXPECTORANT

10 EXTENDED-RELEASE TABLETS

.

*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

Do Not Use

for children under 12 years of age.

Questions Or Comments?

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

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

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

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

Principal Display Panel

NDC 55154-4153-0

MUCUS RELIEF ER

GUAIFENESIN 600 MG

EXPECTORANT

10 EXTENDED-RELEASE TABLETS

.

*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

Do Not Use (Do not use)

for children under 12 years of age.

Questions Or Comments? (Questions or comments?)

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

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