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NDC 81522-0648-10 caring mill nasal four 1 g/100mL Details

caring mill nasal four 1 g/100mL

caring mill nasal four is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by FSA Store Inc.. 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: 81522-0648-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine Nasal Spray

Product Information

NDC	81522-0648
Product ID	81522-648_f13e19d3-9e31-4a04-9c83-0914541e8afc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	caring mill nasal four
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenylephrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	1
Active Ingredient Units	g/100mL
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	FSA Store Inc.
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 81522-0648-10 (81522064810)

Pricing Information	N/A
NDC Package Code	81522-648-10
Billing NDC	81522064810
Package	1 BOTTLE in 1 CARTON (81522-648-10) / 29.6 mL in 1 BOTTLE
Marketing Start Date	2021-10-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ebbcd12a-30a1-44be-a3b7-11fb6684ac26 Details

Active ingredient

Phenylephrine hydrochloride 1%

Purpose

Nasal decongestant

Uses

•: temporarily relieves nasal congestion due to:
•: common cold
•: hay fever
•: upper respiratory allergies

Warnings

Ask a doctor before use if you have

•: heart disease
•: diabetes
•: thyroid disease
•: high blood pressure
•: 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
•: use only as directed
•: 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

•: adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
•: children under 12 years: ask a doctor
•: Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other information

•: store at 20°-25°C (68°-77°F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of 4 Way® Fast Acting Nasal Spray

Nasal Four

Phenylephrine Hydrochloride 1%

Nasal Decongestant

Fast-acting

Nasal Spray

Fast relief of:

• Nasal congestion

• Swollen nasal membranes

• Sinus congestion

• Sinus pressure

1 FL OZ (29.6 mL)

INGREDIENTS AND APPEARANCE

CARING MILL NASAL FOUR

phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81522-648
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81522-648-10	1 in 1 CARTON	10/05/2021
1		29.6 mL in 1 BOTTLE; 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	10/05/2021

Labeler - FSA Store Inc. (049283340)

Revised: 10/2021

Document Id: f13e19d3-9e31-4a04-9c83-0914541e8afc

Set id: ebbcd12a-30a1-44be-a3b7-11fb6684ac26

Version: 2

Effective Time: 20211020