Guaifenesin

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Hypromellose, Unspecified Magnesium Stearate Silicon Dioxide Povidone, Unspecified Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance

Imprint: RH;99 Shape: oval Color: white Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2022-01-12

Medication Information

Purpose

Expectorant

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

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.

Directions

•
do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
•
children under 12 years of age: do not use

Do Not Use

•
for children under 12 years of age

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Other Information

•
store between 20-25°C (68-77°F)
•
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive Ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

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)

Active Ingredient (in Each Extended Release Tablet)

Guaifenesin, USP 1200 mg

Principal Display Panel 1200 Mg Tablet Blister Pack Carton

Compare to Maximum Strength Mucinex^®

active ingredient*

NDC 68196-996-56

Member's Mark_™

Maximum Strength

Mucus Relief

Guaifenesin Extended-Release

Tablets, 1200 mg

Expectorant

•
Relieves chest congestion
•
Thins and loosens mucus

12

HOUR

56

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

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.

Purpose

Expectorant

Directions

•
do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release 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

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Other Information (Other information)

•
store between 20-25°C (68-77°F)
•
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

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)

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

Guaifenesin, USP 1200 mg

Principal Display Panel 1200 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton)

Compare to Maximum Strength Mucinex^®

active ingredient*

NDC 68196-996-56

Member's Mark_™

Maximum Strength

Mucus Relief

Guaifenesin Extended-Release

Tablets, 1200 mg

Expectorant

•
Relieves chest congestion
•
Thins and loosens mucus

12

HOUR

56

Extended-

Release

Tablets

Advanced Ingredient Data

[{"name": "Guaifenesin", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "hypromellose, unspecified", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "silicon dioxide", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "povidone, unspecified", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "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", "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.", "Purpose": "Expectorant", "Directions": "• do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. • children under 12 years of age: do not use", "Do not use": "• for children under 12 years of age", "Questions?": "call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.", "Other information": "• store between 20-25°C (68-77°F) • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.", "Inactive ingredients": "colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.", "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)", "Active ingredient (in each extended-release tablet)": "Guaifenesin, USP 1200 mg", "PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton": "Compare to Maximum Strength Mucinex ® active ingredient* NDC 68196-996-56 Member's Mark ™ Maximum Strength Mucus Relief Guaifenesin Extended-Release Tablets, 1200 mg Expectorant • Relieves chest congestion • Thins and loosens mucus 12 HOUR 56 Extended- Release Tablets"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information