Guaifenesin and Pseudoephedrine HCL GUAIFENESIN AND PSEUDOEPHEDRINE HCL DR. REDDYS LABORATORIES LIMITED FDA Approved Use(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some 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

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient(s) Guaifenesin USP 600 mg................................................................................Expectorant Pseudoephedrine HCl USP 60 mg......................................................Nasal Decongestant Guaifenesin USP 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP 120 mg......................................................Nasal Decongestant
Inactive Ingredients
Inactive ingredients FD & C yellow #6 hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose povidone silicon dioxide.
Strengths
600 mg 60 mg 1200 mg 120 mg
Treats Conditions
Use S Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bother Some 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

Identifiers & Packaging

Container Type UNKNOWN
UNII
6V9V2RYJ8N 495W7451VQ
Packaging

Principal Display Panel Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg: 18s (1x18s); Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg: 24s (2x12s)

Package Descriptions
  • Principal Display Panel Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg: 18s (1x18s)
  • Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg: 24s (2x12s)

Overview

Use(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some 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

Use(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some 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 ■ children under 12 years of age: do not use 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

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 ■ 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 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. Pregnancy/Breastfeeding 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 and Nasal Decongestant

Do Not Use

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.

When Using

When using this product ■ do not use more than directed

Stop Use & Ask a Doctor

Stop use and ask 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.

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).

Storage & Handling

Storage ■ store between 20°-25°C (68°-77°F)

Questions

Questions call 1-888-375-3784 You may also report side effect to this phone number. Keep the carton. It contains important information. See end panel for expiration date. DISTRIBUTED BY: Dr. Reddy’s Laboratories Inc., Princeton, NJ – 08540 Made in India


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