Aurophen infants pain and fever suspension

Drug facts

Active ingredient (in each 5 mL)

Acetaminophen, USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:


  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses 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.

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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor.
  • for more than 3 days for fever unless directed by a doctor.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dose (see overdose warning)

Stop using and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

Keep out of reach of children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (seeoverdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • use only enclosed syringe designed for use with this product. Do not use any other dosing device.
  • remove bottle cap and insert syringe tip through opening at top of the bottle
  • tip bottle upside down and draw medicine into the syringe
  • fill to dose level
  • dispense liquid slowly into childs mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance
Dosing Chart
* or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL

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

Other information

  • each 5 mL contains:sodium 6 mg
  • store at 20-25C (68-77F)
  • do not use if printed bottle body wrap is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-855-274-4122


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

Ingredients and appearance - Product information

Aurophen infants pain and fever suspension- Acetaminophen

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-210
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 160 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Butylparaben ( UNII: 3QPI1U3FV8)
Carboxymethylcellulose sodium, unspecified form ( UNII: K679OBS311)
Glycerin ( UNII: PDC6A3C0OX)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE (White to off-white) Flavor BUBBLE GUM

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part343 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-210)

Package label-principal display panel 1 fl oz (30 ml)

AUROHEALTH
NDC 58602-210-07
Compare to Infants
TYLENOL ®Oral Suspension
active ingredient**
AUROPHEN
INFANTS
PAIN & FEVER
SUSPENSION LIQUID
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
Pain Reliever & Fever Reducer
- Alcohol Free
- Aspirin Free
- Ibuprofen Free
- Gluten Free
Dye-Free
Bubble Gum Flavor
Use ONLY enclosed syringe
1FL OZ (30 mL)

Package label-principal display panel 2 fl oz (59 ml)

AUROHEALTH
NDC 58602-210-11
Compare to Infants
TYLENOL ®Oral Suspension
active ingredient**
AUROPHEN
INFANTS
PAIN & FEVER
SUSPENSION LIQUID
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
Pain Reliever & Fever Reducer
- Alcohol Free
- Aspirin Free
- Ibuprofen Free
- Gluten Free
Dye-Free
Bubble Gum Flavor
Use ONLY enclosed syringe
2 FL OZ (59 mL)