Rugby Guaifenesin Extended Release Tablets 1200 Mg

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Fd&c Blue No. 1 Aluminum Lake Stearic Acid Microcrystalline Cellulose Hypromellose, Unspecified Copovidone K25-31 Maltodextrin Magnesium Stearate Silicon Dioxide Sodium Starch Glycolate Type A Povidone K30

Identifiers & Packaging

Pill Appearance

Imprint: 41;1200 Shape: oval Color: blue Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2025-04-21

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and Administration

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

Description

Drug Facts

Section 50565-1

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.

Section 50566-9

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.

Section 50569-3

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)

Section 50570-1

Do not use

for children under 12 years of age

Section 51727-6

Inactive ingredients

colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active ingredient

(in each extended-release tablet)

Guaifenesin, USP 1200 mg

Section 60561-8

Other information

store at 20-25°C (68-77°F)

Drug Facts

Drug Facts

Structured Label Content

Indications and Usage (34067-9)

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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)

Section 50570-1 (50570-1)

Do not use

for children under 12 years of age

Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active ingredient

(in each extended-release tablet)

Guaifenesin, USP 1200 mg

Section 60561-8 (60561-8)

Other information

store at 20-25°C (68-77°F)

Drug Facts

Drug Facts

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "34068-7": "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", "34071-1": "Warnings", "50565-1": "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.", "50566-9": "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.", "50569-3": "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)", "50570-1": "Do not use for children under 12 years of age", "51727-6": "Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid", "53413-1": "Questions or comments? Call 1-877-290-4008", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Expectorant", "55106-9": "Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg", "60561-8": "Other information store at 20-25°C (68-77°F)", "Drug Facts": "Drug Facts"}

Rugby Guaifenesin Extended Release Tablets 1200 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information