NORTH SINUS DECONGESTANT- phenylephrine tablet 
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-3330 & 0498-3331: Sinus Decongestant

Active Ingredient

Phenylephrine HCl 5 mg

Purpose

Nasal decongestant

Uses

Temporarily relieves

  • nasal congestion due to:the common cold, hay fever, or other respiratory allergies
  • sinus congestion and pressure.

Warnings

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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a health professional before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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
  • sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast feeding

ask a health professional

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center immediately

Directions

  • adults and children 12 years of age and over:
  • take 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours
  • children under 12 years, consult a doctor

Other information

  • store at room temperature
  • Tamper Evident Packets
  • do not use if open or torn

Inactive ingredients

colloidal silica, croscarmellose sodium, D and C Red # 27 Lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, stearic acid, talc

Questions or comments?

1-800-430-5490

Package Label

Sinus relief 250

Honeywell Sinus Decongestant

Sinus decongestant

NORTH SINUS DECONGESTANT 
phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-3330
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorred (Red) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code FR4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-3330-10100 in 1 BOTTLE, UNIT-DOSE06/10/2012
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-3330-25250 in 1 BOX, UNIT-DOSE06/10/2012
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0498-3330-50500 in 1 BOX, UNIT-DOSE06/10/2012
32 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/10/201212/29/2022
SINUS DECONGESTANT 
phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-3331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorred (Red) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code FR4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-3331-10100 in 1 BOTTLE09/18/2018
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-3331-25250 in 1 BOX09/18/2018
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0498-3331-50500 in 1 BOX09/18/2018
32 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/201812/29/2022
Labeler - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
Document Id: 0ecac032-53fa-c456-e063-6294a90a8ea7
Set id: 3314b12f-78a0-47d7-91b9-56289179bfe2
Version: 15
Effective Time: 20240112
 
Honeywell Safety Products USA, Inc