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Childrens Pain Relief by Aurohealth LLC

Medically reviewed on September 13, 2017

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 160mg
Labeler: Aurohealth LLC
NDC Code: 58602-766

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 tablet)

Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

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

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.
  •  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 dosage.

Stop use and ask a doctor if
  • pain gets worse or lasts more than 5 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.

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 (1-800-222-1222) right away. 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)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lb)
Age (yr)
Dose (tablets)*
* or as directed by a doctor
under 24
under 2 years
ask a doctor
24-35
2-3 years
1 tablet
36-47
4-5 years
1½ tablets
48-59
6-8 years
2 tablets
60-71
9-10 years
2½ tablets
72-95
11 years
3 tablets

Other information
  • store at 20° to 25°C (68° to 77°F). Avoid high humidity.
  • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.

Inactive ingredients

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.


Questions or comments?

Call 1-855-274-4122



* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Chewables.

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN



Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)

NDC 58602-766-76
Ages 2-11
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer

 

  • Aspirin Free                         
  • Ibuprofen Free

 


Bubblegum Flavor

Compare to the active ingredient in
Children's Tylenol® Chewables*
24
Chewable Tablets



CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-766
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
SILICON DIOXIDE 
COPOVIDONE K25-31 
CROSPOVIDONE (15 MPA.S AT 5%) 
D&C RED NO. 27 
D&C RED NO. 30 
DEXTROSE MONOHYDRATE 
ETHYLCELLULOSE (4 MPA.S) 
MAGNESIUM STEARATE 
MANNITOL 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize16mm
FlavorBUBBLE GUMImprint CodeF8
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-766-764 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/13/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-766)

 
Aurohealth LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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