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 Kroger Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

In case of overdose, get medical help or contact a Poison Control Center 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
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor

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

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• avoid high humidity
• see end flap for expiration date and lot number

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 or comments?

1-800-632-6900

Principal display panel

COMPARE TO the active ingredient of
CHILDREN’S TYLENOL® CHEWABLES †See bottom panel

Chew or crush
tablets completely
before swallowing.

NDC: 30142-449-08

Kroger®
Ages 2-11

children's
Pain Relief
Acetaminophen 160 mg
Chewable Tablets

Pain Reliever/Fever Reducer
Ibuprofen Free/Aspirin Free

actual size

Grape Flavored

24 CHEWABLE TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†Children's Tylenol® Chewables is a registered trademark
of Johnson & Johnson Corporation, New Brunswick New
Jersey 08933. Johnson & Johnson Corporation is not
affiliated with The Kroger Co. or this product.
50844         REV0522A44908

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

For More Product Information,
Scan UPC Using Your Kroger App or
Call 800-632-6900

Our Brands. Our Guarantee.
Love It or Your Money Back.
www.kroger.com

Kroger 44-449

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-449
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
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
Color	purple	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	GRAPE	Imprint Code	44;449
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-449-08	1 in 1 CARTON	03/18/2021
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/18/2021

Labeler - Kroger Company (006999528)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(30142-449)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(30142-449) , pack(30142-449)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(30142-449)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(30142-449)