CHILDRENS PAIN RELIEVER- acetaminophen tablet, chewable

Childrens Pain Reliever by

Drug Labeling and Warnings

Childrens Pain Reliever by is a Otc medication manufactured, distributed, or labeled by H E B, 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.

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.

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
• any new symptoms appear
• redness or swelling is present

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

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

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• avoid high humidity
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• 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?

1-800-426-9391

Principal display panel

Compare to Children’s Tylenol® Chewables
active ingredient†

NDC: 37808-499-08

H-E-B®

Children's
Pain Reliever
Acetaminophen 160 mg
Chewable Tablets

Pain Reliever/Fever Reducer

For ages 2 to 11

Relieves Pain + Fever
Ibuprofen Free
Aspirin Free

Grape
Flavor

24 CHEWABLE
TABLETS

actual size

Chew or crush tablets
completely before swallowing.
Do not swallow tablets whole.

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

†This product is not manufactured or
distributed by Kenvue Inc., owner of the
registered trademark Children’s Tylenol®
Chewables.

50844        REV0424C44908

H-E-B®
100%
GUARANTEE
promise
If you aren't completely pleased
with this product, we'll be happy to
replace it or refund your money.
You have our word on it.

MADE WITH
PRIDE & CARE FOR H-E-B®
SAN ANTONIO, TX 78204

HEB 44-449

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEVER 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-499
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 ALUMINUM LAKE (UNII: GE75M6YV5W)
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: 37808-499-08	4 in 1 CARTON	02/09/2022
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 Drug	M013	02/09/2022

Labeler - H E B (007924756)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(37808-499)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(37808-499) , pack(37808-499)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(37808-499)