Guaifenesin and Pseudoephedrine HCl GUAIFENESIN AND PSEUDOEPHEDRINE HCL OHM LABORATORIES, 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 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
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Substance Guaifenesin
Route
ORAL
Applications
ANDA212542

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant Active ingredients (in each extended-release tablet) Purposes Guaifenesin 1200 mg Expectorant Pseudoephedrine HCl 120 mg Nasal Decongestant
Inactive Ingredients
Inactive Ingredients carbomer homopolymer NF; hypromellose USP; magnesium stearate NF; microcrystalline cellulose NF
Strengths
600 mg 60 mg 1200 mg 120 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: 057

Identifiers & Packaging

Container Type BOX
UPC
0351660077124 0351660074185
UNII
6V9V2RYJ8N 495W7451VQ
Packaging

Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Tablets - Carton Label NDC 51660-074-18 † Compare To the active ingredients of Mucinex ® D ohm ® Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg Extended-Release Tablets Expectorant & Nasal Decongestant 12 Hour Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release 18 Extended-Release Tablets †Ohm ® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. guaif-pseuso; Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets - Carton Label NDC 51660-077-12 † Compare To the active ingredients of Maximum Strength Mucinex ® D ohm ® Maximum Strength Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets Expectorant & Nasal Decongestant 12 Hour Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release 12 Extended-Release Tablets †Ohm ® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. guai-pseudo-02

Package Descriptions
  • Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Tablets - Carton Label NDC 51660-074-18 † Compare To the active ingredients of Mucinex ® D ohm ® Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg Extended-Release Tablets Expectorant & Nasal Decongestant 12 Hour Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release 18 Extended-Release Tablets †Ohm ® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. guaif-pseuso
  • Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets - Carton Label NDC 51660-077-12 † Compare To the active ingredients of Maximum Strength Mucinex ® D ohm ® Maximum Strength Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets Expectorant & Nasal Decongestant 12 Hour Clears Nasal/Sinus Congestion Thins and Loosens Mucus Immediate and Extended Release 12 Extended-Release Tablets †Ohm ® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. guai-pseudo-02

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 For 600 mg/60 mg: adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 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 Active ingredients (in each extended-release tablet) Purposes Guaifenesin 1200 mg Expectorant Pseudoephedrine HCl 120 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 toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984 You may also report side effects to this phone number. Keep the carton. It contains important information. See end panel for expiration date. † Ohm ® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 0321


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