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NDC 49348-0197-27 Sunmark Nose 1 g/100mL Details

Sunmark Nose 1 g/100mL

Sunmark Nose is a NASAL SOLUTION/ DROPS 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 nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine nasal spray 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: 49348-0197-27
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine Nasal Spray

Product Information

NDC	49348-0197
Product ID	49348-197_d3fc4610-3632-4408-bac8-14cfe80aac74
Associated GPIs	42102050102015
GCN Sequence Number	008072
GCN Sequence Number Description	phenylephrine HCl DROPS 1 % NASAL
HIC3	Q7D
HIC3 Description	NOSE PREPARATIONS, VASOCONSTRICTORS(OTC)
GCN	34186
HICL Sequence Number	002087
HICL Sequence Number Description	PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	Sunmark Nose
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenylephrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	NASAL
Active Ingredient Strength	1
Active Ingredient Units	g/100mL
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 49348-0197-27 (49348019727)

Pricing Information	N/A
NDC Package Code	49348-197-27
Billing NDC	49348019727
Package	1 BOTTLE, DROPPER in 1 CARTON (49348-197-27) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2003-08-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ac576e56-97e3-4091-ad12-ed30c26a9a44 Details

Active ingredient

Phenylephrine hydrochloride 1.0%

Purpose

Nasal decongestant

Uses

•: temporarily relieves nasal congestion due to:
•: common cold
•: hay fever
•: upper respiratory allergies
•: temporarily relieves sinus congestion and pressure
•: shrinks swollen membranes so you can breathe more freely
•: temporarily restores freer breathing through the nose

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

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 use more than directed
•: do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
•: temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
•: use of this container by more than one person may spread infection

Stop use and ask a doctor if

symptoms persist

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•: use only as directed
•: adults and children 12 years of age and older: 2 or 3 drops in each nostril not more often than every 4 hours
•: children under 12 years of age: ask a doctor

Other information

•: store at 20-25°C (68-77°F)
•: Protect from light. Store in outer carton until contents used.

Inactive ingredients

anhydrous citric acid, benzalkonium chloride solution, purified water, sodium chloride, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO NEO-SYNEPHRINE® EXTRA STRENGTH ACTIVE INGREDIENT

nose drops

Phenylephrine HCl 1.0%

Nasal Decongestant

Easy to use & dispense

Fast relief from nasal congestion

EXTRA STRENGTH

GLUTEN FREE

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

SUNMARK NOSE

phenylephrine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-197
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	YELLOW (Clear to slightly yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49348-197-27	1 in 1 CARTON	08/21/2003
1		30 mL in 1 BOTTLE, DROPPER; 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	08/21/2003

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 12/2019

Document Id: d3fc4610-3632-4408-bac8-14cfe80aac74

Set id: ac576e56-97e3-4091-ad12-ed30c26a9a44

Version: 6

Effective Time: 20191228