Guaifenesin and Pseudoephedrine HCl GUAIFENESIN AND PSEUDOEPHEDRINE HCL GRANULES INDIA LTD 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
ANDA216082

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) (For 600 mg/60 mg) Guaifenesin USP 600 mg Pseudoephedrine HCL USP 60 mg (For 1200 mg/120 mg) Guaifenesin USP 1200 mg Pseudoephedrine HCL USP 120 mg
Inactive Ingredients
Inactive ingredients carbomer homopolymer Type B cellulose microcrystalline hypromellose lake of FD&C yellow 6 magnesium stearate sodium starch glycolate Type A
Strengths
600 mg/60 mg 600 mg 60 mg 1200 mg/120 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: orange Imprint: GP;1200

Identifiers & Packaging

Container Type BOX
UPC
0362207828710 0362207827720
UNII
6V9V2RYJ8N 495W7451VQ
Packaging

PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Foil Label ggf-pseudo-600mg-60mg-foil-label; PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label NDC 62207-827-72 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 600 mg and 60 mg Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 60 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 90 (9x10) Extended-Release Tablets ggf-pseudo-600mg-60mg-blistercarton; PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Foil Label ggf-pseudo-1200mg-120mg-foil-label; PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label NDC 62207-828-71 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 1200 mg and 120 mg Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 70 (7x10) Extended-Release Tablets ggf-pseudo-1200mg-120mg-blistercarton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Foil Label ggf-pseudo-600mg-60mg-foil-label
  • PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label NDC 62207-827-72 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 600 mg and 60 mg Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 60 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 90 (9x10) Extended-Release Tablets ggf-pseudo-600mg-60mg-blistercarton
  • PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Foil Label ggf-pseudo-1200mg-120mg-foil-label
  • PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label NDC 62207-828-71 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 1200 mg and 120 mg Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 70 (7x10) Extended-Release Tablets ggf-pseudo-1200mg-120mg-blistercarton

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: For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: 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

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 Centre right away (1-800 222-1222). 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)
Purpose

Purposes Expectorant Nasal Decongestant

When Using

When using this product • do not use more than directed

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222).

Questions

Questions or comments? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. You may also report side effects to this phone number. Keep the carton. It contains important information. See end panel for expiration date. Manufactured By: Granules India Limited Hyderabad – 500 081, INDIA MADE IN INDIA Distributed By: Granules USA, Inc. Parsippany, NJ 07054


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