Otc - Purpose
Active ingredients (in each extended-release tablet) | Purposes |
Guaifenesin 600 mg | Expectorant |
Pseudoephedrine HCl 60 mg | Nasal decongestant |
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.
Active ingredients (in each extended-release tablet) | Purposes |
Guaifenesin 600 mg | Expectorant |
Pseudoephedrine HCl 60 mg | Nasal decongestant |
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.
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 Center right away (1-800-222-1222).
carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF
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.
*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Mucinex D ®.
Distributed by:
RUGBY
® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Rev. 07/26 R-59 Re-order No. 371291 & 371292
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
* Please review the disclaimer below.