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Sinus and Allergy

EQUALINE (SuperValu)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

Sinus and Allergy Uses

  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • 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
  • glaucoma
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • thyroid disease
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by a fever

If pregnant or breast-feeding,

ask a health care 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

  • take every 4 hours
  • do not take more than 6 doses in 24 hours
 adults and children 12 years of age and older  take 1 tablet
 children 6 to under 12 years of age  take 1/2 tablet
 children under 6 years of age  consult a doctor
 children under 4 years of age  do not use

Sinus and Allergy Other information

  • each tablet contains: calcium 10 mg/tablet
  • store at 15º-30ºC (59º-86ºF)

Inactive ingredients

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized starch, sodium starch glycolate and stearic acid

Questions or comments?

Call toll free 1-877-932-7948

Principal Display Panel

Compare to Maximum Strength Sudafed PE® Sinus & Allergy active ingredients*

Sinus & Allergy PE

Chlorpheniramine Maleate / Phenylephrine HCl

antihistamine / nasal congestion

tablets

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT.

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

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN  55344 USA

PRODUCT OF USA

Product Label

Sinus and Allergy
Equaline Sinus & Allergy PE Tablet

Sinus and Allergy

Chlorpheniramine maleate, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41163-810
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
Mineral Oil
STARCH, CORN
sodium starch glycolate type a corn
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm T127 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:41163-810-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-12-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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