AUROMINE CHILDRENS COLD AND ALLERGY- brompheniramine maleate and phenylephrine hcl solution

Auromine Childrens Cold and Allergy by

Drug Labeling and Warnings

Auromine Childrens Cold and Allergy by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

AUROHEALTH

NDC: 58602-158-24
*Compare to the active ingredients
in Children's Dimetapp®
Cold & Allergy

Children's
Auromine
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

4 FL OZ
(118 mL)

Grape Flavor

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237 mL Bottle)

AUROHEALTH

NDC: 58602-158-20
*Compare to the active ingredients
in Children's Dimetapp®
Cold & Allergy

Children's
Auromine
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

INGREDIENTS AND APPEARANCE

AUROMINE CHILDRENS COLD AND ALLERGY 
brompheniramine maleate and phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-158
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-158-24	1 in 1 CARTON	12/15/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-158-20	1 in 1 CARTON	12/15/2015
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/15/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-158)