AUROFLU FLU AND SORE THROAT WARMING RELIEF- acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup

AuroFlu Flu and Sore Throat Warming Relief by

Drug Labeling and Warnings

AuroFlu Flu and Sore Throat Warming Relief by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each dose cup 15 mL)

Acetaminophen USP 325 mg
Diphenhydramine HCl USP 12.5 mg
Phenylephrine HCl USP 5 mg

Purpose

Fever Reducer/Pain Reliever
Cough Suppressant/Antihistamine
Nasal Decongestant

Uses

• temporarily relieves
  • minor aches and pains
  • headache
  • minor sore throat pain
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily reduces fever

Warnings

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

• more than 6 doses (180 mL) in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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

• in a child under 4 years of age
• if you are allergic to acetaminophen
• with any other product containing acetaminophen (prescription or non-prescription). 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.
• with any other drug containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• 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

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
• avoid alcoholic drinks
• marked drowsiness may occur
• 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

• nervousness, dizziness, or sleeplessness occurs
• pain, cough or nasal congestion 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 a fever, 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 use more than directed
• take every 4 hours, while symptoms persist
• do not take more than 6 doses (12 dose cups) (180 mL) (6 fl oz) in 24 hours
• use dosage cup provided
• mL = milliliter

• age: dose
• children under 4 years of age: do not use
• children 4 to under 12 years of age: do not use unless directed by a doctor
• adults and children 12 years of age and over: 30 mL (2 dose cups) (1 fl oz) every 4 hours

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• each 15 mL contains: sodium 7 mg
• each 15 mL contains: potassium 5 mg
• store at 20-25oC (68-77oF)
• TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing
• see back panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red # 40, flavor, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

1-855-274-4122

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Flu & Sore Throat.

Failure to follow the drug facts warnings could result in serious consequences. 

PARENTS:
Learn about teen medicine abuse

www.StopMedicineAbuse.org

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-8.3 FL OZ (245 mL Bottle)

AUROHEALTH

NDC: 58602-120-33

AuroFlu

Compare to the active
ingredients in Theraflu®
Warming Relief Flu & Sore Throat*

Flu & Sore Throat
Warming Relief 

Each dose (per 15 mL) of Syrup contains:
325 mg – ACETAMINOPHEN
(Fever Reducer/Pain Reliever)
12.5 mg - DIPHENHYDRAMINE HCl
(Cough Suppressant/Antihistamine)
5 mg - PHENYLEPHRINE HCl
(Nasal Decongestant)

• Nasal congestion
• Sore throat
• Runny Nose
• Headache
• Body ache
• Cough
• Fever

8.3 FL OZ (245 mL)
Cherry Flavor
Alcohol Content: 10%

INGREDIENTS AND APPEARANCE

AUROFLU FLU AND SORE THROAT WARMING RELIEF 
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-120
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
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED (Red Colored Liquid)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-120-33	245 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/21/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-120)