AUROFLU NIGHT TIME SEVERE COLD AND COUGH WARMING RELIEF- acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup

AuroFlu Night Time Severe Cold and Cough Warming Relief by

Drug Labeling and Warnings

AuroFlu Night Time Severe Cold and Cough 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 HCI USP 5 mg

Purpose

Fever Reducer/Pain Reliever
Cough Suppressant/Antihistamine
Nasal Decongestant

Uses

• temporarily relieves
  • minor aches and pains
  • sneezing
  • headache
  • minor sore throat pain
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation 
  • runny nose
  • itchy, watery eyes
  • itchy nose or throat
• 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

  

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.

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

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

• to make a child sleepy
• if you are on a sodium-restricted diet
• 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 two 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 product containing diphenhydramine, even one used on skin
• with any other acetaminophen containing products. This may lead to an overdose, which may cause liver damage. (see overdose warning)

Ask a doctor before use if you have

• glaucoma
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough accompanied by excessive phlegm (mucus)
• trouble urinating due to enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• do not use more than directed (see overdose warning)
• 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

• redness or swelling is present
• you get nervous, dizzy or sleepless
• pain, cough or nasal congestion gets worse or lasts more than7 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
• 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 this and all drugs out of the reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. 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 exceed recommended dosage (see overdose warning)
• do not use in infants

age	dose
adults and children 12 years and over	30 mL (2 dose cups) (1fl oz) every 4 hours
children 4 years to under 12 years	do not use unless directed by a doctor
children under 4 years	do not use
Do not take more than 6 doses (12 dose cups) (180 mL) (6 fl oz) in 24 hours

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

Other information

• sodium content per 15 mL: 7.09 mg
• potassium content per 15 mL: 4.66 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®.

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: 58602-140-33

AuroFlu

Compare to the active
ingredients in Theraflu®
Warming Relief Nighttime*

Night Time Severe 
Cold & Cough 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
• Runny Nose
• Cough
• Fever
• Body ache
• Sore throat
• Headache

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

INGREDIENTS AND APPEARANCE

AUROFLU NIGHT TIME SEVERE COLD AND COUGH WARMING RELIEF 
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-140
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: 58602-140-33	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(58602-140)