Active Ingredient (In Each Tablet)
Pseudoephedrine HCl 30 mg
Sinus And Congestion Tablet, Film Coated
FDA Label NDC 49035-780
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Sinus And Congestion (NDC 49035-780). 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 ingredient (in each 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
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- 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
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever
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 and over | take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours |
| children ages 6 to 11 years | take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours |
| children under 6 years | do not use |
Other Information
- each tablet contains: calcium 15 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin
Questions Or Comments?
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equate™
Compare to Sudafed®
Sinus Congestion
active ingredient*
Non-Drowsy
Nasal Decongestant
Sinus & Congestion
Pseudoephedrine HCl 30 mg
Nasal decongestant
MAXIMUM STRENGTH
Relieves:
• Sinus congestion • Sinus pressure
Actual Size
30
mg EACH
24
TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Satisfaction guaranteed - For questions or
comments please call 1-888-287-1915.
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA, GERMANY, AND INDIA
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Sudafed® Sinus Congestion.
50844 ORG061911208
Equate 44-112 (Equate 44 112 1)
* Please review the disclaimer below.
