Guaifenesin Extended Release 600 mg, Guaifenesin Extended Release 1200 mg GUAIFENESIN TIME CAP LABORATORIES, INC. FDA Approved INDICATIONS & USAGE SECTION Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
FunFoxMeds box
Substance Guaifenesin
Route
ORAL
Applications
ANDA217780

Drug Facts

Composition & Profile

Active Ingredients
OTC - ACTIVE INGREDIENT SECTION For 600 mg: Active ingredient (in each extended-release tablet) Guaifenesin USP 600 mg For 1200 mg: Active ingredient (in each extended-release tablet) Guaifenesin USP 1200 mg
Inactive Ingredients
INACTIVE INGREDIENT SECTION 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
Strengths
600 mg 1200 mg
Treats Conditions
Indications Usage Section Uses Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive
Pill Appearance
Shape: oval Color: white Imprint: 41

Identifiers & Packaging

Container Type UNKNOWN
UPC
0349483724707 0349483723502
UNII
495W7451VQ
Packaging

PRINCIPAL DISPLAY PANEL guaifenesin-1200mg-70ct-label guaifenesin-600mg-500ct-label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL guaifenesin-1200mg-70ct-label guaifenesin-600mg-500ct-label

Overview

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

Indications & Usage

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

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION Directions For 600 mg • 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 or 2 extended - release tablets every 12 hours. Do not exceed 4 extended - release tablets in 24 hours. • children under 12 years of age: do not use For 1200 mg • 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 & Precautions
WARNINGS SECTION
Purpose

OTC - PURPOSE SECTION Purpose Expectorant

Do Not Use

OTC - DO NOT USE SECTION Do not use • for children under 12 years of age

Stop Use & Ask a Doctor

OTC - STOP USE SECTION 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION 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.

Storage & Handling

STORAGE AND HANDLING SECTION Other information • store at 20-25°C (68-77°F)

Questions

OTC - QUESTIONS SECTION Questions or comments? Call 1-877-290-4008


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