AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF- acetaminophen, phenylephrine hcl, and dextromethorphan hbr solution

AuroQuil COLD and FLU Day Time Multi-Symptom Relief by

Drug Labeling and Warnings

AuroQuil COLD and FLU Day Time Multi-Symptom Relief by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

PURPOSE

Active ingredients (in each 15 mL tablespoon)                      Purpose

Acetaminophen, USP 325 mg …………………......…………Pain reliever/fever reducer

Dextromethorphan HBr, USP 10 mg ………….......………….Cough suppressant

Phenylephrine HCl, USP 5 mg …………………............……..Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever

Warnings

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
• 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

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

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

• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• 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 headache that lasts.

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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed – see Overdose warning
• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses (60 mL) (4 TBSP) per 24 hours
• mL = milliliter; TBSP = tablespoon

• adults & children 12 years & over: 30 mL (2 TBSP) every 4 hours
• children 6 to under 12 years: 15 mL (1 TBSP) every 4 hours
• children 4 to under 6 years: ask a doctor
• children under 4 years: do not use

• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

• each 15 mL contains: sodium 49 mg
• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose  sodium, edetate disodium, FD&C Yellow no. 6, flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions or Comments?

1-855-274-4122

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

AUROHEALTH

NDC: 58602-125-18

Compare to the active ingredients
in Vicks® DayQuil® COLD & FLU
Multi-Symptom Relief*

AuroQuil
COLD & FLU
Day Time
Multi-Symptom Relief

Each dose (per 15 mL) (1 TBSP) of oral solution contains:
325 mg - Acetaminophen USP (Pain reliever/fever reducer)
5 mg - Phenylephrine HCl USP (Nasal decongestant)
10 mg - Dextromethorphan HBr USP (Cough suppressant)

• Aches, Fever & Sore Throat
• Nasal Congestion
• Cough

Non-Drowsy                                                   6 FL OZ
Alcohol Free/Antihistamine Free                  (177 mL)

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

AUROHEALTH

NDC: 58602-125-20

Compare to the active ingredients
in Vicks® DayQuil® COLD & FLU
Multi-Symptom Relief*

AuroQuil
COLD & FLU
Day Time
Multi-Symptom Relief

Each dose (per 15 mL) (1 TBSP) of oral solution contains:
325 mg - Acetaminophen USP (Pain reliever/fever reducer)
5 mg - Phenylephrine HCl USP (Nasal decongestant)
10 mg - Dextromethorphan HBr USP (Cough suppressant)

• Aches, Fever & Sore Throat
• Nasal Congestion
• Cough

Non-Drowsy                                                   8 FL OZ
Alcohol Free/Antihistamine Free                  (237 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

AUROHEALTH

NDC: 58602-125-16

Compare to the active ingredients
in Vicks® DayQuil® COLD & FLU
Multi-Symptom Relief*

AuroQuil
COLD & FLU
Day Time
Multi-Symptom Relief

Each dose (per 15 mL) (1 TBSP) of oral solution contains:
325 mg - Acetaminophen USP (Pain reliever/fever reducer)
5 mg - Phenylephrine HCl USP (Nasal decongestant)
10 mg - Dextromethorphan HBr USP (Cough suppressant)

• Aches, Fever & Sore Throat
• Nasal Congestion
• Cough

Non-Drowsy                                                   12 FL OZ
Alcohol Free/Antihistamine Free                  (354 mL)

INGREDIENTS AND APPEARANCE

AUROQUIL COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF 
acetaminophen, phenylephrine hcl, and dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ORANGE (UNII: 5EVU04N5QU)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	ORANGE (Orange to Reddish Brown)	Score
Shape		Size
Flavor	APRICOT, ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-125-18	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015
2	NDC: 58602-125-20	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015
3	NDC: 58602-125-16	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/27/2015

Labeler - Aurohealth LLC (078728447)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-125)