CHILDRENS PAIN RELIEVER GRAPE FLAVOR- acetaminophen tablet, chewable

Childrens Pain Reliever by

Drug Labeling and Warnings

Childrens Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Valu Merchandisers Company, 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:
  • headache
  • the common cold
  • flu
  • toothache
  • sore throat
• 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

• if your child is allergic to acetaminophen or any of the inactive ingredients in this product
• 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.

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

Directions

• do not give more than directed
  (see overdose warning)
• this product does not contain directions or complete warnings for adult use
• find the 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
• do not give for more than 5 days unless directed by a doctor

Weight (lb)	Age (yr)	Dose (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

 *or as directed by a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
• avoid high humidity
• protect from light
• 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, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Product Packaging

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® MELTAWAYS®†

Best Choice®

Children's
Pain Reliever

ACETAMINOPHEN

Pain Reliever/Fever Reducer
Quick Melts
Aspirin Free Ibuprofen Free
GRAPE FLAVOR    AGES 2-6

30 Tablets - 80 mg each

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

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.
50844        REV1013D45201

PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106

Best Choice 44-452

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEVER  GRAPE FLAVOR
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-452
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CROSPOVIDONE (UNII: 2S7830E561)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
DEXTRATES (UNII: G263MI44RU)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	13mm
Flavor	GRAPE	Imprint Code	44;452
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-452-01	1 in 1 CARTON	12/06/2004
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	12/06/2004

Labeler - Valu Merchandisers Company (868703513)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(63941-452)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(63941-452)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(63941-452)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(63941-452)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(63941-452)