foster and thrive mucus relief GUAIFENESIN STRATEGIC SOURCING SERVICES LLC 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
ANDA078912
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each extended-release tablet) Guaifenesin 600 mg
Inactive Ingredients
Inactive ingredients carbomer homopolymer type B FD&C blue #1 aluminum lake hypromellose magnesium stearate microcrystalline cellulose sodium starch glycolate
Strengths
600 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
Pill Appearance
Shape: oval Color: blue Imprint: L2X2

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
495W7451VQ
Packaging

Package/Label Principal Display Panel COMPARE TO MUCINEX® EXTENDED RELEASE TABLETS 600 mg ACTIVE INGREDIENT Foster & Thrive™ REGULAR STRENGTH Mucus Relief Guaifenesin Extended-Release Tablets, 600 mg EXPECTORANT 12 Hour • Relieves Chest Congestion • Thins & Loosens Mucus • Immediate and Extended Release Gluten Free ACTUAL SIZE 100 EXTENDED-RELEASE TABLETS foster&thrive-mucus-relief-carton-image.jpg

Package Descriptions
  • Package/Label Principal Display Panel COMPARE TO MUCINEX® EXTENDED RELEASE TABLETS 600 mg ACTIVE INGREDIENT Foster & Thrive™ REGULAR STRENGTH Mucus Relief Guaifenesin Extended-Release Tablets, 600 mg EXPECTORANT 12 Hour • Relieves Chest Congestion • Thins & Loosens Mucus • Immediate and Extended Release Gluten Free ACTUAL SIZE 100 EXTENDED-RELEASE TABLETS foster&thrive-mucus-relief-carton-image.jpg

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 the 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. • 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 or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST


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