SINUS PLUS ALLERGY PE MAXIMUM STRENGTH- chlorpheniramine maleate, phenylephrine hcl tablet

sinus plus allergy PE by

Drug Labeling and Warnings

sinus plus allergy PE by is a Otc medication manufactured, distributed, or labeled by United Natural Foods, Inc. dba UNFI, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 this product in children under 12 years of age

Other information

• 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

EQUALINE®

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;462
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-666-08	1 in 1 CARTON	06/09/2005
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

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	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(41163-666)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(41163-666)