Sinus Plus Allergy PE Maximum Strength: Package Insert and Label Information

SINUS PLUS ALLERGY PE MAXIMUM STRENGTH- chlorpheniramine maleate and phenylephrine hydrochloride tablet
SUPERVALU INC.

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 ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg

Purpose

Antihistamine
Nasal decongestant

Uses

  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • sinus congestion and pressure
    • nasal congestion

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

  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

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 (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: do not use

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, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-877-932-7948

Principal Display Panel

EQUAL INE®

NDC 41163-666-08

compare to Sudafed PE® Sinus + Allergy active ingredients*

maximum strength
sinus + allergy PE

chlorpheniramine maleate 4 mg
(antihistamine)
phenylephrine HCl 10mg
(nasal decongestant)

relieves:
•sneezing, itchy eyes, runny nose
•sinus pressure & congestion

24 tablets

PSEUDOEPHEDRINE FREE

actual size

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

DOES NOT CONTAIN GLUTEN

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Sinus + Allergy.

50844 REV0319A46208

DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRE, MN 55344 USA

877-932-7948
supervaluprivatebrands.com

Equaline 44-462
(click image for full-size original)

Equaline 44-462

SINUS PLUS ALLERGY PE MAXIMUM STRENGTH
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-666
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STEARIC ACID
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 44;462
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41163-666-08 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (41163-666-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/09/2005
Labeler — SUPERVALU INC. (006961411)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (41163-666)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (41163-666)

Revised: 09/2021 SUPERVALU INC.

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.