Guaifenesin Extended-release Tablets

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Carbomer Homopolymer, Unspecified Type Fd&c Blue No. 1 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Marketing Status

ANDA Active Since 2020-09-10

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 1200 mg)

Uses

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

Section 51945-4

C'rcle Guaifenesin Extended-Release Tablets

600 mg / Expectorant

100 (20x5) Extended-Release Bi-Layer Tablets

C'rcle Guaifenesin Extended-Release Tablets

1200 mg / Expectorant

56 (14x4) Extended-Release Bi-Layer Tablets

Warnings

Directions

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. (For 600mg)
adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
children under 12 years of age: do not use

Do Not Use

for children under 12 years of age

Questions?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Other Information

Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

store between 20-25°C (68-77°F)

Active Ingredient

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)

Inactive Ingredients

carbomer homopolymer type B; hypromellose, Lake of FD&C Blue 1, magnesium stearate, microcrystalline cellulose; sodium starch glycolate

If Pregnant Or Breast Feeding

ask a health professional before use.

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.

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)

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 51945-4 (51945-4)

C'rcle Guaifenesin Extended-Release Tablets

600 mg / Expectorant

100 (20x5) Extended-Release Bi-Layer Tablets

C'rcle Guaifenesin Extended-Release Tablets

1200 mg / Expectorant

56 (14x4) Extended-Release Bi-Layer Tablets

Purpose

Expectorant

Warnings

Directions

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. (For 600mg)
adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
children under 12 years of age: do not use

Do Not Use (Do not use)

for children under 12 years of age

Questions?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Other Information (Other information)

Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

store between 20-25°C (68-77°F)

Active Ingredient (Active ingredient )

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; hypromellose, Lake of FD&C Blue 1, magnesium stearate, microcrystalline cellulose; sodium starch glycolate

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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.

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)

Advanced Ingredient Data

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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", "51945-4": "C'rcle Guaifenesin Extended-Release Tablets 600 mg / Expectorant 100 (20x5) Extended-Release Bi-Layer Tablets C'rcle Guaifenesin Extended-Release Tablets 1200 mg / Expectorant 56 (14x4) Extended-Release Bi-Layer Tablets", "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 timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. (For 600mg) adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg) children under 12 years of age: do not use", "Do not use": "for children under 12 years of age", "Questions?": "Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.", "Other information": "Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. store between 20-25°C (68-77°F)", "Active ingredient ": "Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 1200 mg)", "Inactive ingredients": "carbomer homopolymer type B; hypromellose, Lake of FD&C Blue 1, magnesium stearate, microcrystalline cellulose; sodium starch glycolate", "If pregnant or breast-feeding": " ask a health professional before use.", "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.", "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)"}

Guaifenesin Extended-release Tablets

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information