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Drug Facts
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RUGBY® LABORATORIES
Livonia, MI 48152
Guaifenesin D Tablet, Extended Release
FDA Label NDC 0536-1333
Full FDA labeling including 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 D (NDC 0536-1333). 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 other, otc - purpose, uses, 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.
Label Section Quick Index
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
Otc - Do Not Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 1-800-645-2158. You may also report side effects to this phone number.
Principal Display Panel - 36 Tablet Blister Pack Carton
Rugby®
NDC 0536-1333-36
Compare to the active
ingredients in Mucinex® D†
Guaifenesin and
Pseudoephedrine HCl
Extended-Release Tablets
Guaifenesin 600 mg
Pseudoephedrine HCl 60 mg
600 mg/60 mg
Expectorant and Nasal Decongestant
12 Hour
- Clears Nasal/Sinus Congestion
- Thins and Loosens Mucus
- Immediate and Extended Release
Actual Size
36 Extended-Release Tablets
Principal Display Panel (36 Tablet Blister Pack Carton)
* Please review the disclaimer below.
