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NDC 81522-0094-23 caring mill Sinus PE 10 mg/1 Details

caring mill Sinus PE 10 mg/1

caring mill Sinus PE is a ORAL TABLET, FILM COATED 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 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: 81522-0094-23
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	81522-0094
Product ID	81522-094_cfe59650-e3b4-4246-8fe8-9885c496f308
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 Sinus PE
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	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 81522-0094-23 (81522009423)

Pricing Information	N/A
NDC Package Code	81522-094-23
Billing NDC	81522009423
Package	12 BLISTER PACK in 1 CARTON (81522-094-23) / 6 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2022-01-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dd540fe7-0302-407d-afdd-c0b6c9818611 Details

Active ingredient (in each tablet)

Phenylephrine HCl 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	ask a doctor

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

caring mill™

Compare to the active ingredient of Sudafed PE® Congestion

Non-Drowsy • Maximum Strength

Sinus PE

Nasal Decongestant

Phenylephrine HCl, 10 mg each

Sinus Pressure

Nasal & Sinus Congestion

72 Tablets

Actual Size

INGREDIENTS AND APPEARANCE

CARING MILL SINUS PE

phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81522-094
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:81522-094-23	12 in 1 CARTON	01/12/2022
1		6 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	01/12/2022

Labeler - FSA Store Inc. (049283340)

Revised: 1/2022

Document Id: cfe59650-e3b4-4246-8fe8-9885c496f308

Set id: dd540fe7-0302-407d-afdd-c0b6c9818611

Version: 2

Effective Time: 20220121