Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 mg GUAIFENESIN INNOVUS PHARMACEUTICALS, INC. FDA Approved Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Substance Guaifenesin
Route
ORAL
Applications
ANDA213420

Drug Facts

Composition & Profile

Active Ingredients
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
Strengths
600 mg 1200 mg
Treats Conditions
Uses Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive

Identifiers & Packaging

Container Type UNKNOWN
UNII
495W7451VQ
Packaging

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 image description image description

Package Descriptions
  • 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 image description image description

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings Do not use for children under 12 years of age 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) 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)
Purpose

Purpose Expectorant

Do Not Use

Do not use for children under 12 years of age

Stop Use & Ask a Doctor

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)

Questions

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


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