Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 51660-074

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ohm Laboratories, Inc. for the product Guaifenesin And Pseudoephedrine Hcl (NDC 51660-074). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, directions, other information, inactive ingredients, questions?, guaifenesin 600 mg and pseudoephedrine hcl 60 mg extended-release tablets - carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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

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 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.

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)

Inactive Ingredients

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

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

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 Pseudo 01)

    Guaif-pseuso (Guaifenesin Pseudo 01)

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 (Guaifenesin Pseudo 02)

    Guai-pseudo-02 (Guaifenesin Pseudo 02)

* Please review the disclaimer below.