AUROTUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Aurotussin Peak Cold Maximum Strength Multi-Symptom Cold by

Drug Labeling and Warnings

Aurotussin Peak Cold Maximum Strength Multi-Symptom Cold by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Phenylephrine HCl, USP 10 mg

Purposes

Cough suppressant
Expectorant
Nasal decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with a cold:
       nasal congestion
       cough due to minor throat and bronchial irritation

Warnings

Do not use

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
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed

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
cough lasts more than 7 days, comes back, or is accompanied by fever, 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.

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

Directions

• shake well before using 
• do not take more than 6 doses (12 tsp) in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age

• Age: Dose
• adults and children12 years and over: 10 mL; every 4 hours
• children under 12 years: do not use

Other information

• each 10 mL contains: sodium 7 mg
• store at 20-25°C (68-77°F). Do not refrigerate

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavors, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or Comments

1-855-274-4122

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

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

AUROHEALTH

NDC: 58602-143-20

Compare to the active ingredient
in Robitussin® Peak Cold
Maximum Strength Multi-Symptom Cold*

ADULT

Aurotussin
PEAK COLD
MAXIMUM STRENGTH
Multi-Symptom Cold

Each 10 mL dose of oral solution contains:
20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
400 mg - Guaifenesin, USP (Expectorant)
10 mg- Phenylephrine HCl, USP (Nasal Decongestant)

Relieves:

Nasal Congestion
Cough
Mucus

Pineapple Flavor
Non-Drowsy                                       8 FL OZ
For Ages 12 & Over                           (237 mL)

INGREDIENTS AND APPEARANCE

AUROTUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-143
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LEVOMENTHOL (UNII: BZ1R15MTK7)
ORANGE (UNII: 5EVU04N5QU)
PINEAPPLE (UNII: 2A88ZO081O)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	ORANGE, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-143-24	1 in 1 CARTON	02/19/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-143-20	1 in 1 CARTON	02/19/2016
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	02/19/2016

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-143)