Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Silicon Dioxide Hypromellose 2208 (15000 Mpa.s) Hypromellose 2910 (10000 Mpa.s) Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: L;69 Shape: oval Color: white Size: 21 mm Score: 1

Marketing Status

ANDA Active Since 2022-06-29

Medication Information

Purpose

Expectorant

Description

( in each extended-release tablet) 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

Warnings

Do not use

for children under 12 years of age

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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: do not use

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.

DISTRIBUTED BY:RITE AID,

30 HUNTER LANE, CAMP HILL,

PA 17011 www.riteaid.com

MADE IN INDIA

Code: AP/DRUGS/04/2016

Active Ingredient

( in each extended-release tablet)

Guaifenesin USP 1200 mg

Other Information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

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)

Package Label Principal Display Panel 1200 Mg Blister Carton (14 (1 x 14) tablets)

Compare to the active Ingredient in Maximum Strength Mucinex^®*

NDC 11822-4260-1

MAXIMUM STRENGTH

MUCUS

RELIEF

GUAIFENESIN EXTENDED-RELEASE

TABLETS 1200 mg

EXPECTORANT

Relieves chest congestion

Thins & loosens mucus

12

HOUR 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

Purpose

Expectorant

Warnings

Do not use

for children under 12 years of age

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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: do not use

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.

DISTRIBUTED BY:RITE AID,

30 HUNTER LANE, CAMP HILL,

PA 17011 www.riteaid.com

MADE IN INDIA

Code: AP/DRUGS/04/2016

Active Ingredient (Active ingredient)

( in each extended-release tablet)

Guaifenesin USP 1200 mg

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

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

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)

Package Label Principal Display Panel 1200 Mg Blister Carton (14 (1 x 14) tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets))

Compare to the active Ingredient in Maximum Strength Mucinex^®*

NDC 11822-4260-1

MAXIMUM STRENGTH

MUCUS

RELIEF

GUAIFENESIN EXTENDED-RELEASE

TABLETS 1200 mg

EXPECTORANT

Relieves chest congestion

Thins & loosens mucus

12

HOUR ACTUAL SIZE

14

EXTENDED-RELEASE

TABLETS

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2208 (15000 MPA.S)", "unii": "Z78RG6M2N2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (10000 MPA.S)", "unii": "0HO1H52958", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 101", "unii": "7T9FYH5QMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 102", "unii": "PNR0YF693Y", "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", "Purpose": "Expectorant", "Warnings": "Do not use for children under 12 years of age", "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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: do not use", "Questions?": "1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com MADE IN INDIA Code: AP/DRUGS/04/2016", "Active ingredient": "( in each extended-release tablet) Guaifenesin USP 1200 mg", "Other information": "store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)", "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)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)": "Compare to the active Ingredient in Maximum Strength Mucinex ® * NDC 11822-4260-1 MAXIMUM STRENGTH MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE TABLETS 1200 mg EXPECTORANT Relieves chest congestion Thins & loosens mucus 12 HOUR ACTUAL SIZE 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