Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 0536-1488

15 label sections · Submitted to the FDA by Rugby Laboratories, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories, Inc. for the product Guaifenesin And Pseudoephedrine Hcl (NDC 0536-1488). 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, otc - do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

Active ingredients (in each extended-release tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 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

Warnings

Otc - 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).

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: 2 extended-release tablets every 12 hours; not more than 4 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.

Guaifenesin 600 Mg And Pseudoephedrine Hcl 60 Mg Extended-Release Tablets - Carton Label

RUGBY ®

NDC 0536-1488-21

compare to the active ingredients in Mucinex D ®*

mucus relief D

guaifenesin 600 mg &

pseudoephedrine HCI 60 mg

extended-release tablets

expectorant & nasal decongestant

12 hour

• clears nasal/sinus congestion
• thins and loosens mucus
• immediate and extended release

Actual Size

18 extended-release tablets

Carton (Rugby Guaifenesin 600mg Pse60mg 18ctcarton)

Carton (Rugby Guaifenesin 600mg Pse60mg 18ctcarton)

* Please review the disclaimer below.