Sinus Congestion Relief
FDA Label NDC 82501-1577

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gobrands, Inc for the product Sinus Congestion Relief (NDC 82501-1577). 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 drug facts, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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.

Otc - Ask Doctor

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes
• trouble urinating due to an enlarged prostate gland

Otc - When Using

When using this product do not exceed recommended dose

Otc - Stop Use

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever

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

adults & children 12 years & over
  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours
children under 12 yearsask a doctor

Other Information

• store between 20-25°C (68-77°F)

Inactive Ingredients

colloidal silicon dioxide, D&C yellow#10 aluminum lake, FD&C Blue#1, FD&C Red #40, hypromellose, magnesium stearate, microcrytalline cellulose, polyethylene glycol, starch, sodium starch glycolate, talc, titanium dioxide

Questions Or Comments?

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Compare to active
ingredient in Sudafed PE®
Sinus Congestion†

NDC 82501-1577-1

Good now

Sinus Congestion Relief PE
Phenylephrine HCl Tablets, 10 mg

24 TABLETS

Nasal Decongestant

Relief of
Nasal & Sinus Congestion
Sinus Pressure

* Please review the disclaimer below.