Auroflu night time severe cold and cough warming relief syrup

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 alcoholicdrinks 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 aretaking 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

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 20-25 oC (68-77 oF)
  • 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

Ingredients and appearance - Product information

Auroflu night time severe cold and cough warming relief syrup- Acetaminophen, diphenhydramine hcl and phenylephrine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-140
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 15 mL
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 12.5 mgin 15 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 15 mL

Inactive Ingredients

Ingredient Name Code
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) Flavor CHERRY

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 58602-140-33 245mL in 1 BOTTLE 2015/02/21

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2015/02/21

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-140)

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%