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NDC 49348-0700-07 sunmark nasal decongestant pe 10 mg/1 Details

sunmark nasal decongestant pe 10 mg/1

sunmark nasal decongestant pe is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 49348-0700-07
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	49348-0700
Product ID	49348-700_06a40e28-bd73-4556-a977-787747522d59
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	sunmark nasal decongestant pe
Proprietary Name Suffix	maximum strength
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	Strategic Sourcing Services LLC
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 49348-0700-07 (49348070007)

Pricing Information
NDC Package Code	49348-700-07
Billing NDC	49348070007
Package	2 BLISTER PACK in 1 CARTON (49348-700-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2005-02-14
NDC Exclude Flag	N
Price Per Unit	0.05079
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	SM NASAL DECONG PE 10 MG TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 140dec71-7933-4d38-870a-9233061222c8 Details

Active ingredient (in each tablet)

Phenylephrine HCI 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

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

•: nervousness, dizziness, or sleeplessness occur
•: symptoms do not improve within 7 days or occur with a fever

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 right away (1-800-222-1222).

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	do not use this product in children under 12 years of age

Other information

•: store at 20-25°C (68-77°F)
•: do not use if blister unit is broken or torn

Inactive ingredients

anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO SUDAFED PE® CONGESTION

ACTIVE INGREDIENT

nasal decongestant PE

Maximum Strength

Phenylephrine HCl Tablets, 10 mg

Nasal & sinus congestion - Sinus pressure

36 doses - 1 pill/dose

GLUTEN FREE

NON-DROWSY

Actual Size

36 TABLETS 10 mg EACH

INGREDIENTS AND APPEARANCE

SUNMARK NASAL DECONGESTANT PE MAXIMUM STRENGTH

phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-700
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L7
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49348-700-48	1 in 1 CARTON	02/14/2005
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:49348-700-07	2 in 1 CARTON	02/14/2005
2		18 in 1 BLISTER PACK; 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	02/14/2005

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 1/2021

Document Id: 06a40e28-bd73-4556-a977-787747522d59

Set id: 140dec71-7933-4d38-870a-9233061222c8

Version: 5

Effective Time: 20210104