guaifenesin extended-release tablets 

guaifenesin extended-release tablets 
SPL v1
SPL
SPL Set ID bba4b91a-bea9-41be-9588-5fb1483c7d10
Route
oral
Published
Effective Date 2023-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Expectorant

Description

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


Medication Information

Warnings

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make 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 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

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)

Inactive Ingredients

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

Description

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

Questions?

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

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

Do Not Use
  • for children under 12 years of age
Active Ingredient 

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)

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

Warnings

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make 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 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

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)

Inactive Ingredients (Inactive ingredients)

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

Questions?

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

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

Do Not Use (Do not use)
  • for children under 12 years of age
Active Ingredient  (Active ingredient )

Guaifenesin 600 mg (for 600 mg)

Guaifenesin 1200 mg (for 1200 mg)

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


Raw Label Data

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