Your browser does not support JavaScript! SINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [EQUALINE (SUPERVALU)]
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RxNorm Names

SINUS AND ALLERGY (chlorpheniramine maleate, phenylephrine hcl) tablet
[EQUALINE (SuperValu)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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
    • 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

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

Chlorpheniramine maleate 4 mg, Phenylephrine HCl 10 mg

Equaline Sinus & Allergy PE Tablet

SINUS AND ALLERGY 
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41163-810
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code T127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-810-241 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/07/2011
Labeler - EQUALINE (SuperValu) (006961411)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
 
EQUALINE (SuperValu)

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