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Aurophen - Adult Extra Strength Pain Reliever/Fever Reducer

Medically reviewed on December 11, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL
Labeler: Aurohealth LLC
NDC Code: 58602-215

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.

Drug Facts

Active ingredient (in each 15 mL)

Acetaminophen USP 500 mg

Purpose

Pain reliever/Fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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.

Do not use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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) may cause 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 take more than directed (see overdose warning)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over
  • take 30 mL in dose cup provided every 4 to 6 hours while symptoms last
  • do not take more than 120 mL in 24 hours
  • do not take more than 10 days unless directed by a doctor
children under 12 years
  • do not use this adult product in children under 12 years of age this will provide more than the recommended dose (overdose) and may cause liver damage

Other information
  • each 15 mL contains: sodium 7 mg
  • store at 20-25° C (68-77° F).
  • dosage cup provided
  • do not use if printed shrinkband is missing or broken.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red 33, FD&C red 40,flavors, high fructose corn syrup, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sucralose.

Questions or Comments?

1-855-274-4122

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

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

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

AUROHEALTH

Compare to the active

ingredients in TYLENOL®

Extra Strength Adult Rapid Blast Cherry


NDC 58602-215-20

AUROPHEN

Pain Reliever

Fever Reducer

Extra Strength

Adult Acetaminophen oral Liquid 500mg/15 mL

Rapid Burst                           8 FL OZ (237 mL)

Cherry Flavor

Do not use if printed shrinkband is missing or broken.

AUROPHEN - ADULT EXTRA STRENGTH PAIN RELIEVER/FEVER REDUCER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-215
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
D&C RED NO. 33 
FD&C RED NO. 40 
CHERRY 
MENTHOL 
HIGH FRUCTOSE CORN SYRUP 
SORBITOL 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-215-201 BOTTLE in 1 CARTON
1237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/05/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-215)

 
Aurohealth LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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