Guaifenesin and Pseudoephedrine HCl GUAIFENESIN AND PSEUDOEPHEDRINE HCL 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 temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure
FunFoxMeds box
Substance Guaifenesin
Route
ORAL
Applications
ANDA212542
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant
Inactive Ingredients
Inactive Ingredients carbomer homopolymer NF; hypromellose USP; magnesium stearate NF; microcrystalline cellulose NF
Strengths
600 mg 60 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 Temporarily Relieves Nasal Congestion Due To Common Cold Hay Fever Upper Respiratory Allergies Temporarily Restores Freer Breathing Through The Nose Promotes Nasal And Or Sinus Drainage Temporarily Relieves Sinus Congestion And Pressure
Pill Appearance
Shape: oval Color: white Imprint: 058

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
495W7451VQ 6V9V2RYJ8N
Packaging

Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Tablets - Carton Label NDC 70677-1263-1 COMPARE TO THE ACTIVE INGREDIENTS OF MUCINEX ®D Foster & Thrive TM 12 HOUR Mucus Relief D Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg Extended-Release Tablets EXPECTORANT & NASAL DECONGESTANT Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release ACTUAL SIZE 18 EXTENDED-RELEASE TABLETS guai-pseudo-foster-thrive

Package Descriptions
  • Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Tablets - Carton Label NDC 70677-1263-1 COMPARE TO THE ACTIVE INGREDIENTS OF MUCINEX ®D Foster & Thrive TM 12 HOUR Mucus Relief D Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg Extended-Release Tablets EXPECTORANT & NASAL DECONGESTANT Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release ACTUAL SIZE 18 EXTENDED-RELEASE TABLETS guai-pseudo-foster-thrive

Overview

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Dosage & Administration

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours 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)

Warnings & Precautions
Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days, come back or occur with a 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

Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant

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? Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST Keep the carton. It contains important information. See end panel for expiration date. *All trademarks are property of their respective owners. This product is not affliated with the makers/owners of Mucinex® D. ©2023 McKesson Corporation Distributed by: McKesson Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141 Money Back Guarantee www.fosterandthrive.com Rev. 11/2024


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