Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Nasal Decongestant Pe Tablet, Film Coated
FDA Label NDC 37808-453
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Nasal Decongestant Pe (NDC 37808-453). 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 dose.
Stop Use And Ask A Doctor If
- symptoms do not improve within 7 days or occur with fever
- nervousness, dizziness, or sleeplessness occur
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 and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: ask a doctor
Other Information
- 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, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Compare to Sudafed PE® Congestion
active ingredient*
NDC 37808-453-23
H • E • B ®
Maximum Strength
NASAL
DECONGESTANT PE
Phenylephrine HCl 10 mg /
Nasal Decongestant
Sinus Decongestant
Non-Drowsy
Relief of:
• Congestion
• Sinus Pressure
actual
size
72 TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Sudafed PE® Congestion.
50844 ORG071545323
DOES NOT CONTAIN GLUTEN
MADE WITH PRIDE AND CARE FOR H-E-B®
SAN ANTONIO, TX 78204
100%
GUARANTEE
promise
H-E-B®
If you aren't completely pleased
with this product, we'll be happy to
replace it or refund your money.
You have our word on it.
Heb 44-453 (Heb 44 453 1)
* Please review the disclaimer below.
