COLD AND ALLERGY PE- chlorpheniramine maleate and phenylephrine hydrochloride tablet 
The Kroger Co

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.

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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 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

Inactive ingredients

colloidal silicon dioxide, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, sodium starch glycolate and stearic acid.

Questions or comments?

1-800-632-6900

Principal Display Panel

KROGER®

Compare to active ingredients of Actifed® Cold & Allergy - *See back panel

DOES NOT CONTAIN PSEUDOEPHEDRINE

Maximum Strength Cold & Allergy PE

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

  • Nasal Congestion
  • sneezing
  • Runny Nose
  • itchy, watery eyes

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

Distributed by

The Kroger Co.

Cincinnati, Ohio 45202

Product Label

 Kroger Cold and Allergy PE 24 count

Cold and Allergy PE

COLD AND ALLERGY PE 
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-890
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, ANHYDROUS 
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 Description
1NDC:30142-890-241 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/02/2011
Labeler - The Kroger Co (006999528)

Revised: 08/2012
Document Id: 5e51f100-7634-4295-8314-f11a826c3040
Set id: 22e963d0-a778-40cc-b6ec-94299885c156
Version: 1
Effective Time: 20120822
 
The Kroger Co