FDA Label for Guaifenesin And Pseudoephedrine Hcl
View Indications, Usage & Precautions
Guaifenesin And Pseudoephedrine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Ohm Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients (in each extended-release bi-layer tablet) | Purposes |
Guaifenesin 600 mg | Expectorant |
Pseudoephedrine HCl 60 mg | Nasal Decongestant |
Active ingredients (in each extended-release bi-layer tablet) | Purposes |
Guaifenesin 1200 mg | Expectorant |
Pseudoephedrine HCl 120 mg | Nasal Decongestant |
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
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 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)• do not use more than directed• 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.
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Directions
• do not crush, chew, or break 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 tablets every 12 hours; not more than 4 tablets in 24 hours• For 1200 mg/120 mg: adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 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)
Inactive Ingredients
carbomer homopolymer, NF; FD&C Yellow #6; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF
Questions?
call 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
0219
Guaifenesin 600 Mg And Pseudoephedrine Hcl 60 Mg Extended-Release Bi-Layer Tablets - Carton Label
NDC 51660-058-18
†Compare To
the active ingredients of
Mucinex® D
ohm®
Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg
Extended-Release Bi-Layer Tablets
Expectorant & Nasal Decongestant
12 Hour
• Clears Nasal/Sinus Congestion• Thins and Loosens Mucus• Immediate and Extended Release
18 Extended-Release Bi-Layer Tablets
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
Guaifenesin 1200 Mg And Pseudoephedrine Hcl 120 Mg Extended-Release Bi-Layer Tablets - Carton Label
NDC 51660-057-12
†Compare To
the active ingredients of
Mucinex® D
ohm®
Maximum Strength
Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg
Extended-Release Bi-Layer Tablets
Expectorant & Nasal Decongestant
12 Hour
• Clears Nasal/Sinus Congestion• Thins and Loosens Mucus• Immediate and Extended Release
12 Extended-Release Bi-Layer Tablets
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
* Please review the disclaimer below.