Cold and Allergy

Manufacturer
Hy-Vee
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:09:33

Label at a glance#

ProductCold and Allergy Maximum strength
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

take every 4 hours do not take more than 6 doses in any 24-hour period   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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma 
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur 
  • symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 hours
  • do not take more than 6 doses in any 24-hour period
  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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-289-8343 Monday-Friday 9AM-4PM CST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*COMPARE TO the Active Ingredients in Actifed® Cold & Allergy

Cold & Allergy

Chlorpheniramine maleate, 4mg - Antihistamine

Phenylephrine HCI, 10mg - Nasal Decongestant

Maximum Strength

Relief from:

  • Nasal Congestion
  • Runny Nose
  • Itchy, Watery Eyes
  • Sneezing

TABLETS

One Tablet Dose

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Actifed® Cold & Allergy.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY HY-VEE, INC.

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

www.hy-vee.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HY-VEE Cold & Allergy Maximum Strength Tablets
HY-VEE Cold & Allergy Maximum Strength Tablets

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42507-89042507-890-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e56fd2c9-e410-4b36-8384-723bc9bc2c1d6c45f15e-ef94-4794-b027-cbc934b24cb42020-10-28WarningsExact identifier
spl id: e56fd2c9-e410-4b36-8384-723bc9bc2c1d
spl set id: 6c45f15e-ef94-4794-b027-cbc934b24cb4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.