Auro tap childrens cold and allergy solution

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 20-25 oC (68-77 oF)

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 byPfizer Consumer Healthcare, distributors of Childrens Dimetapp ®Cold & Allergy

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

Ingredients and appearance - Product information

Auro tap childrens cold and allergy solution- Brompheniramine maleate and phenylephrine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-101
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Brompheniramine maleate ( UNII: IXA7C9ZN03)( Brompheniramine - UNII: H57G17P2FN ) 1 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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

Color PURPLE Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-101)

Package label-principal display panel - 4 fl oz (118 ml bottle)

AUROHEALTH

NDC 58602-101-24
*Compare to the active ingredients
in Children's Dimetapp®
Cold & Allergy

Children's
Auro Tap
Clod & Allergy

Each dose (per 5 mL) (1tsp) 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

For Ages
6 years
& Over

Alcohol Free

4FL OZ
(118 mL)

Grape Flavor

Package label-principal display panel - 8 fl oz (237 ml bottle)

AUROHEALTH

NDC 58602-101-20
*Compare to the active ingredients
in Children's Dimetapp®
Cold & Allergy

Children's
Auro Tap
Clod & Allergy

Each dose (per 5 mL) (1tsp) 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

For Ages
6 years
& Over

Alcohol Free

8 FL OZ
(237 mL)

Grape Flavor