Active Ingredients (In Each Immediate-Release Tablet)
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Sinus Congestion Pe
FDA Label NDC 68788-0845
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals, Inc. for the product Sinus Congestion Pe (NDC 68788-0845). 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 active ingredients (in each immediate-release tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
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 the common cold, hay fever or other upper respiratory allergies
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
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
- difficulty 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 exceed recommended dosage.
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- cough comes back or worsens
- symptoms do not improve within 7 days, come back or occur with fever, rash or persistent headache. These could be signs of a serious condition.
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.
Directions
- adults and children 12 years of age and older: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours.
- children under 12 years of age: do not use
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid
Principal Display Panel
MAJOR®
NDC 68788-0845
Mucus Relief
Sinus
Guaifenesin 400 mg /
Phenylephrine HCl 10 mg
Expectorant / Nasal Decongestant
- Alleviates Chest Congestion
- Relieves Nasal/Sinus Congestion
- Does Not Contain Pseudoephedrine
Immediate
Release
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV0612D54201
Distributed by Major Pharmaceuticals
31778 Enterprise Drive, Livonia, MI 48150 USA
Rev. 12/14 M-17 Re-order No. 006474
Repackaged By: Preferred Pharmaceuticals Inc.
Musuc Relief Sinus Expectorant/nasal Decongestant Tablet (Major 44 542 1)
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