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NDC 47682-0809-46 Medi-First Sinus Decongestant 10 mg/1 Details

Medi-First Sinus Decongestant 10 mg/1

Medi-First Sinus Decongestant is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 47682-0809-46
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	47682-0809
Product ID	47682-809_da556d22-e560-f4a8-e053-2995a90afcdd
Associated GPIs	42101040100310
GCN Sequence Number	058496
GCN Sequence Number Description	phenylephrine HCl TABLET 10 MG ORAL
HIC3	B6V
HIC3 Description	DECONGESTANTS, ORAL
GCN	23944
HICL Sequence Number	002087
HICL Sequence Number Description	PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	Medi-First Sinus Decongestant
Proprietary Name Suffix	n/a
Non-Proprietary Name	PHENYLEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Unifirst First Aid Corporation
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 47682-0809-46 (47682080946)

Pricing Information	N/A
NDC Package Code	47682-809-46
Billing NDC	47682080946
Package	1 TABLET, FILM COATED in 1 PACKET (47682-809-46)
Marketing Start Date	2008-12-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9654f5cd-74d7-44a2-9674-666d1e94ffa7 Details

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

SPL UNCLASSIFIED SECTION

Purpose

Nasal decongestant

SPL UNCLASSIFIED SECTION

Uses

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

SPL UNCLASSIFIED SECTION

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 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
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

SPL UNCLASSIFIED SECTION

Directions

do not use more than directed

Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours.

Children under 12 years: Ask a doctor

SPL UNCLASSIFIED SECTION

Other information

store at room temperature 59º-86º F (15º-30º C)
tamper evident sealed packets
do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Medi-First Sinus Decongestant Label

100 Tablets

(100 x 1)

Medi-First®

Sinus Decongestant

Compare active ingredients to:

Sudafed® PE

Registered Trademark of Pfizer Consumer

Nasal Decongestant ● Phenylephrine HCl 10mg

Tamper Evident Unit Dose Packets

Medi-First Plus Sinus Decongestant Label

100 Tablets

(100 x 1's)

Medi-First® Plus

Sinus Decongestant

Phenylephrine HCl 10mg

Pull To Open

Pseudoephedrine Free

Sinus Relief

Compare active ingredient to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

MEDI-FIRST SINUS DECONGESTANT

phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-809
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (red)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	272
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-809-64	24 in 1 BOX	12/30/2008
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-809-33	100 in 1 BOX	12/30/2008
2		1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC:47682-809-48	250 in 1 BOX	12/30/2008
3		1 in 1 PACKET; Type 0: Not a Combination Product
4	NDC:47682-809-13	500 in 1 BOX	12/30/2008
4	NDC:47682-809-46	1 in 1 PACKET; Type 0: Not a Combination Product
5	NDC:47682-809-46	1 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/30/2008

MEDI-FIRST PLUS SINUS DECONGESTANT

phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-990
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (red)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	272
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-990-33	100 in 1 BOX	04/18/2019
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-990-48	250 in 1 BOX	04/18/2019
2		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/18/2019

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 3/2022

Document Id: da556d22-e560-f4a8-e053-2995a90afcdd

Set id: 9654f5cd-74d7-44a2-9674-666d1e94ffa7

Version: 12

Effective Time: 20220316

Search by Drug Name or NDC

NDC 47682-0809-46 Medi-First Sinus Decongestant 10 mg/1 Details

Medi-First Sinus Decongestant 10 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 47682-0809-46 (47682080946)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9654f5cd-74d7-44a2-9674-666d1e94ffa7 Details

Drug Facts

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Medi-First Sinus Decongestant Label

Medi-First Plus Sinus Decongestant Label

INGREDIENTS AND APPEARANCE

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