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AuroFlu Night Time Severe Cold and Cough Warming Relief

Medically reviewed on Apr 24, 2018

Dosage form: syrup
Ingredients: ACETAMINOPHEN 325mg in 15mL, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Aurohealth LLC
NDC Code: 58602-140

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

AuroFlu Night Time Severe Cold and Cough Warming Relief

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%

AUROFLU NIGHT TIME SEVERE COLD AND COUGH WARMING RELIEF 
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-140
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
CHERRY 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
Product Characteristics
ColorRED (Red Colored Liquid) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-140-33245 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/21/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-140)

 
Aurohealth LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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