Aurophen Childrens Pain and Fever: Package Insert and Label Information

AUROPHEN CHILDRENS PAIN AND FEVER — acetaminophen suspension
Aurohealth LLC

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 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 child’s 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°-25°C (68°-77°F)
  • 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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL)

AUROHEALTH
NDC 58602-221-24
** Compare to Children’s TYLENOL®
Oral Suspension active ingredient
Ages 2-11 years
CHILDREN’S
Pain &
Fever
SUSPENSION LIQUID
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
Pain Reliever & Fever Reducer
- Alcohol Free
- Aspirin Free
— Ibuprofen Free
- Gluten Free
Cherry Flavor
Use ONLY enclosed dosage cup
4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL)

AUROHEALTH

NDC 58602-221-20

Compare to Children’s TYLENOL

Oral Suspension active ingredient

Ages 2-11 years

CHILDREN’S

PAIN &

FEVER

SUSPENSION LIQUID

ACETAMINOPHEN

ORAL SUSPENSION

160 mg per 5 mL

Pain Reliever & Fever Reducer

- Alcohol Free

- Aspirin Free

- Ibuprofen Free

- Gluten Free

Cherry Flavor

Use ONLY enclosed dosage cup

8 FL OZ (236 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL)
(click image for full-size original)

AUROPHEN CHILDRENS PAIN AND FEVER acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-221
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
FD&C RED NO. 40
CHERRY
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color RED Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58602-221-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (58602-221-24)
2 NDC:58602-221-20 1 BOTTLE in 1 CARTON contains a BOTTLE
2 236 mL in 1 BOTTLE This package is contained within the CARTON (58602-221-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 05/02/2015
Labeler — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
Aurohealth LLC 078728447 ANALYSIS (58602-221), MANUFACTURE (58602-221)

Revised: 02/2020 Aurohealth LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.