Sinus PE Decongestant Maximum Strength: Package Insert and Label Information

SINUS PE DECONGESTANT MAXIMUM STRENGTH- phenylephrine hydrochloride tablet, film coated
CVS Pharmacy

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.

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

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 dose.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with 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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVS Health

Compare to the active ingredient in Sudafed PE® Congestion*

NDC 59779-953-23

Non-Drowsy
Sinus PE Decongestant

PHENYLEPHRINE HYDROCHLORIDE
Nasal decongestant

MAXIMUM STRENGTH

Relieves
• Sinus pressure
• Nasal congestion

72 TABLETS

Actual Size

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 McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion.
50844 REV0715A45323

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

V-19849

√ CVS® Quality
Money Back Guarantee

CVS Health 44-453
(click image for full-size original)

CVS Health 44-453

SINUS PE DECONGESTANT MAXIMUM STRENGTH
phenylephrine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-953
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DEXTROSE MONOHYDRATE
FD&C RED NO. 40
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
SILICON DIOXIDE
TRISODIUM CITRATE DIHYDRATE
LECITHIN, SOYBEAN
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color red Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 44;453
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-953-23 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 24 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59779-953-23)
2 NDC:59779-953-07 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 18 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59779-953-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/14/2005 04/24/2022
Labeler — CVS Pharmacy (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (59779-953)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (59779-953)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (59779-953)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (59779-953)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (59779-953)

Revised: 11/2021 CVS Pharmacy

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.