Active Ingredients(In Each Immediate-Release Tablet)
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Mucus Relief Pe Sinus Congestion Tablet, Film Coated
FDA Label NDC 70000-0141
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Mucus Relief Pe Sinus Congestion (NDC 70000-0141). 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 (1-800-222-1222) 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 numberÂ
Inactive Ingredients
hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 70000-0141-1
LEADER™
Mucus Relief PE
Sinus Congestion
Guaifenesin, 400 mg | Phenylephrine HCl, 10 mg
Expectorant | Nasal Decongestant
Relieves Nasal / Sinus Congestion
Thins and Loosens Mucus
Alleviates Chest Congestion
Immediate-Release
Easy to Swallow
50 TABLETS
ACTUAL SIZE
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
© 2017 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.
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Return to place of purchase if not satisfied.
Leader 44-542 (Leader 44 542 1)
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