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 CARDINAL HEALTH, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever / fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • flu
  • 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

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 right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• dissolve in mouth or chew before swallowing
• find the right dose on chart. If possible, use weight to dose; otherwise, use age.
• if needed, 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)	Tablets
under 24	under 2	Ask a doctor
24-35	2-3	2
36-47	4-5	3
48-59	6-8	4
60-71	9-10	5
72-95	11	6

Other information

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

Inactive ingredients

citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Product Packaging

LEADER®

NDC: 37205-516-65

AGES 2-6

Compare to Children's Tylenol® Meltaways® active ingredient*

CHILDREN'S
Pain Reliever

Acetaminophen 80 mg
Pain Reliever/Fever Reducer

Ibuprofen Free
Aspirin Free         Rapid Melts

30 TABLETS

Bubble Gum Flavor

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

50844     REV0412C44701

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

CIN 3674793
www.myleader.com
1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Leader 44-447

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEVER 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-516
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	13mm
Flavor	BUBBLE GUM	Imprint Code	44;447
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-516-65	1 in 1 CARTON	02/03/2005	08/29/2020
1		30 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 NOT FINAL	part343	02/03/2005	08/29/2020

Labeler - CARDINAL HEALTH (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(37205-516)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(37205-516)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(37205-516)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(37205-516)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(37205-516)