CHILDREN PAIN RELIEF- children pain relief tablet, chewable 
Allegiant Health

----------

440 - Children Pain Relief

Active ingredient(s)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Use(s)

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

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

Weight (lb)Age (yr)Dose (chewable tablets)**
Under 24
Under 2
Ask a doctor
24-35
2-3
1 tablet
36-47
4-5
1 1/2 tablets
48-59
6-8
2 tablets
60-71
9-10
2 1/2 tablets
72-95
11
3 tablets

**or as directed by a doctor

Other information

Inactive ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake,

dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol,

polyethylene, stearic acid, sucralose

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Principal Display Panel

Acetaminophen 160mg

Acetaminophen 160mg


CHILDREN PAIN RELIEF 
children pain relief tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTRATES (UNII: G263MI44RU)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpurpleScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-440-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/18/2023
Labeler - Allegiant Health (079501930)

Revised: 7/2023
Document Id: 002d3925-b6c2-46c6-bc21-68926caa58ff
Set id: 44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096
Version: 5
Effective Time: 20230717
 
Allegiant Health