Aurophen childrens 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:Taking more than the recommended dose (overdose) may cause liver damage. 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 (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your childs dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
* 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
36-47
4-5 years
7.5 mL
48-59
6-8 years
10 mL
60-71
9-10 years
12.5 mL
72-95
11 years
15 mL

Attention:use only enclosed dosing cup 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 seal over cap is torn or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, FD&C red no #40, 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 childrens pain and fever suspension- Acetaminophen

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-208
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)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Strawberry ( UNII: 4J2TY8Y81V)
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 RED Flavor STRAWBERRY

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( 58602-208)

Package label-principal display panel 4 fl oz (118 ml)

AUROHEALTH
NDC 58602-208-24
Compare to Children's
TYLENOL ®Oral Suspension
active ingredient**
Ages 2-11 years
AUROPHEN
CHILDREN'S
PAIN & FEVER
SUSPENSION LIQUID
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
PainReliever/Fever Reducer
- Alcohol Free
- Aspirin Free
- Ibuprofen Free
- Gluten Free
Strawberry Flavor
Use ONLY enclosed dosage cup
4FL OZ (118 mL)