Childrens Cold and Allergy

Manufacturer
Aurohealth LLC
Effective date
2020-11-26
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:45

Label at a glance#

ProductChildrens Cold and Allergy
Active ingredientBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product do not use any other dosing device tsp=teaspoon, mL = milliliter Age Dose  adults and children 12 years and over  20 mL (4 tsp) every 4 hours  children 6 to under 12 years  10 mL (2 tsp) every 4 hours  children under 6 years   do not use   

Storage and handling

each 5 mL contains: sodium 2 mg store at 20-25 o C (68-77 o F) see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL (1 tsp) dose)

Brompheniramine maleate, USP 1 mg
Phenylephrine HCl, USP 2.5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION


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

Warnings

WARNINGS SECTION

Do not use

  • to sedate a child or to make a child sleepy
  • 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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosage cup with product
  • do not use any other dosing device
  • tsp=teaspoon, mL = milliliter

Age
Dose
 adults and children 12 years and over
 20 mL (4 tsp) every 4 hours
 children 6 to under 12 years
 10 mL (2 tsp) every 4 hours
 children under 6 years
  do not use   

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 2 mg
  • store at 20-25oC (68-77oF)
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, FD&C Blue No.1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or Comments?

1-855-274-4122

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children’s Dimetapp® Cold & Allergy

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-506-24
PrimaryHealth
COMPARE TO Children's
Dimetapp®
 Cold & Allergy
active ingredients*
 
For Ages 6 years & Over
Children's
Cold &
Allergy

Each dose (per 5 mL) (1 tsp)
of oral solution contains:
Brompheniramine maleate, USP 1 mg -
Antihistamine
Phenylephrine HCl, USP 2.5 mg -
Nasal Decongestant

Relieves Nasal Symptoms:

  • Stuffy Nose
  • Runny Nose
  • Sneezing

Plus Other Symptoms:

  • Itchy, Watery Eyes

 

Alcohol Free
Grape Flavor

4 FL OZ (118 mL)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-50658602-506-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
7ca6c927-d908-4780-a6ea-fac019916a9a2549712e-edcf-4853-bd74-67fa6bb306e62020-11-26WarningsExact identifier
spl id: 7ca6c927-d908-4780-a6ea-fac019916a9a
spl set id: 2549712e-edcf-4853-bd74-67fa6bb306e6

Reported adverse events (FAERS/openFDA)#

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