NORTH SINUS DECONGESTANT- phenylephrine tablet SINUS DECONGESTANT- phenylephrine tablet

Sinus Decongestant by

Drug Labeling and Warnings

Sinus Decongestant by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, Honeywell Safety products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Honeywell Sinus Decongestant

INGREDIENTS AND APPEARANCE

NORTH SINUS DECONGESTANT 
phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-3330
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (Red)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	FR4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-3330-10	100 in 1 BOTTLE, UNIT-DOSE	06/10/2012
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-3330-25	250 in 1 BOX, UNIT-DOSE	06/10/2012
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-3330-50	500 in 1 BOX, UNIT-DOSE	06/10/2012
3		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/10/2012

SINUS DECONGESTANT 
phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-3331
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (Red)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	FR4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-3331-10	100 in 1 BOTTLE	09/18/2018
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-3331-25	250 in 1 BOX	09/18/2018
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-3331-50	500 in 1 BOX	09/18/2018
3		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/18/2018

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-3330, 0498-3331)