SINUS PE- phenylephrine hcl tablet, film coated
Target Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Target 44-453

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
diabetes
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

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

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.

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

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions?

Call 1-800-910-6874

Principal display panel

Compare to active ingredient in
Sudafed PE® Sinus Congestion*

NDC 11673-453-07

congestion,
non-drowsy
sinus PE

phenylephrine HCl tablets,
nasal decongestant

sinus pressure and congestion
maximum strength
pseudoephedrine free

up & up™

ACTUAL SIZE

36
TABLETS

36 TABLETS (10 mg EACH)

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Sudafed PE® Sinus Congestion.
50844 ORG082045307

094 03 0434 R00 C-001472-01-109
Distributed by Target Corporation
Minneapolis, MN 55403
TM & ©2021 Target Brands, Inc.

Target 44-453

SINUS PE
phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11673-453
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;453
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11673-453-07	2 in 1 CARTON	06/17/2021
1		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	06/17/2021

Labeler - Target Corporation (006961700)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(11673-453)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(11673-453)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(11673-453)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(11673-453)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(11673-453)

Revised: 6/2021

Document Id: 16ff0e2e-a24a-4a97-ba67-441e6dd54b1a

Set id: 015758ca-d566-414b-bf2e-6e966372e490

Version: 2

Effective Time: 20210617

Target Corporation