CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable

Childrens Pain Relief by

Drug Labeling and Warnings

Childrens Pain Relief by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, FD &C Blue No.1 lake, 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)

AUROHEALTH
NDC: 58602-765-76
Ages 2-11
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer
 

• Aspirin Free                         
• Ibuprofen Free

 
Grape Flavor

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

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-765
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	GRAPE	Imprint Code	J26
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-765-76	4 in 1 CARTON	09/13/2017
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	09/13/2017

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-765)