AUROMUCUS - FAST MAXIMUM COLD AND SINUS- acetaminophen, guaifenesin and phenylephrine hydrochloride solution

AuroMucus - Fast Maximum Cold and Sinus by

Drug Labeling and Warnings

AuroMucus - Fast Maximum Cold and Sinus 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 20 mL (4 tsp) dose)

Acetaminophen, USP 650 mg
Guaifenesin, USP 400 mg
Phenylephrine HCl, USP 10 mg

Purposes

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • minor aches and pains
  • sore throat
  • headache
  • nasal congestion
  • sinus congestion and pressure
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4, 000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for children under 12 years of age
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients Avoid foods or beverages that contain caffeine

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

When using this product

• do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see Overdose warning)
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• mL = milliliter; tsp = teaspoon
• Adults and children 12 years and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
• Children under 12 years of age: do not use unless directed by a doctor

Other information

• Each 20 mL contains: sodium 12 mg
• Store at 20-25°C (68-77°F)
• tamper evident: do not use if printed seal under cap is torn or missing
• do not refrigerate
• dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, 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 6 FL OZ (180 mL Bottle)

AUROHEALTH

NDC: 58602-111-18

Compare to the active ingredients in

Mucinex® FAST-MAXTM

Cold & Sinus*

MAXIMUM STRENGTH**

AuroMucus

Fast Maximum

Cold & Sinus

Each dose 20 mL (4 tsp) of oral solution contains:

650 mg - Acetaminophen USP (Pain Reliever/Fever Reducer)

400 mg - Guaifenesin USP (Expectorant)

10 mg - Phenylephrine HCl USP (Nasal Decongestant)

• Relieves Headache & Fever
• Relieves Nasal & Chest Congestion
• Thins & Loosens Mucus

For Ages 12+                         6 FL OZ (180 mL)

INGREDIENTS AND APPEARANCE

AUROMUCUS - FAST MAXIMUM COLD AND SINUS 
acetaminophen, guaifenesin and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PINEAPPLE (UNII: 2A88ZO081O)
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	BLUE (Blue to Bluish Green)	Score
Shape		Size
Flavor	BERRY, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-111-18	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/18/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-111)