AUROMUCUS - CHILDRENS STUFFY NOSE AND COLD- guaifenesin and phenylephrine hydrochloride solution

AuroMucus - Childrens Stuffy Nose and Cold by

Drug Labeling and Warnings

AuroMucus - Childrens Stuffy Nose and Cold 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 (tsp) dose)

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 2.5 mg

Purposes

Expectorant
Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • nasal congestion due to a cold
  • stuffy nose

Warnings

Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Avoid foods or beverages that contain caffeine.

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma

Do not exceed recommended dosage.

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor

Stop use and ask a doctor if

• your child gets nervous, dizzy or sleepless
• symptoms do not get better within 7 days or occur with fever
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• measure only with dosing cup provided
• do not use dosing cup with other products
• mL= milliliter; tsp = teaspoon

• Age: Dose
• Children 4 years to 6 years: 5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
• Children 6 years to 12 years: 10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
• Children under 4 years: do not use unless directed by a doctor

Other information

• each 5 mL contains: sodium 3 mg
• tamper evident: do not use if printed seal under cap is torn or missing
• store at 20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Questions or Comments?

1-855-274-4122
You may also report side effects to this phone number.

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

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

AUROHEALTH

NDC: 58602-152-24
Compare to the
active ingredients in
Children’s Mucinex®
Stuffy Nose & Cold*

AuroMucus
Children's
Stuffy Nose and Cold

Each dose 5 mL (1 tsp) of oral solution contains:
Guaifenesin, USP 100 mg
Phenylephrine HCl, USP 2.5 mg

Expectorant
Nasal decongestant

 Stuffy Nose
 Chest Congestion
 Breaks up Mucus

DOSING CUP
INCLUDED
Alcohol-free

For Ages 4+

Mixed Berry
Flavor Syrup

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

AUROMUCUS - CHILDRENS STUFFY NOSE AND COLD 
guaifenesin and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-152
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MANGO (UNII: I629I3NR86)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (Pink to Red)	Score
Shape		Size
Flavor	BERRY, MANGO	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-152-24	1 in 1 CARTON	06/29/2015
1		118 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	06/29/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-152)