Childrens Cold and Allergy

Childrens Cold and Allergy

Drug Labeling and Warnings

Drug Details

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CHILDRENS COLD AND ALLERGY - brompheniramine maleate and phenylephrine hcl solution 
Aurohealth LLC

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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Childrens Cold and Allergy

Drug Facts

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

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

Purposes

Antihistamine
Nasal decongestant

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

Warnings

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

  • 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

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

When using this product

  • 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

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by 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 (1-800-222-1222) right away.

Directions

  • 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

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

Inactive ingredients

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)

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)

CHILDRENS COLD AND ALLERGY 
brompheniramine maleate and phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-506
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GRAPE (UNII: 6X543N684K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-506-241 in 1 CARTON09/10/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/10/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-506)

Revised: 9/2018
 
Aurohealth LLC


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