PAIN RELIEVER CHILDREN- acetaminophen tablet, chewable

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by L&R Distributors, Inc., 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

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 dose.

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 accidental 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
• do not give more than directed
• 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

• phenylketonurics: Contains Phenylalanine 6 mg per tablet
• 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

corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, ethylcellulose, flavor, magnesium stearate, mannitol, NutraSweet (aspartame), polyethylene, stearic acid

Questions or comments?

1-800-426-9391

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NDC: 15127-185-01

Ibuprofen Free
Aspirin Free

Ages 2-6
Children's
Pain Reliever
Acetaminophen 80 mg
PAIN RELIEVER / FEVER REDUCER

†Compare to the Active Ingredient of Children’s Tylenol® Meltaways®

30 Chewable Tablets

Fruit Flavored

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      REV0416A18501

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA
AC (870) 535-3635

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brand®
SATISFACTION
GUARANTEED

Select Brand 44-185

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  CHILDREN
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-185
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
ASPARTAME (UNII: Z0H242BBR1)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	10mm
Flavor	FRUIT	Imprint Code	44;185
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-185-01	1 in 1 CARTON	09/06/2001	08/29/2020
1		30 in 1 BOTTLE; 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	09/06/2001	08/29/2020

Labeler - L&R Distributors, Inc. (012578514)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(15127-185)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(15127-185)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(15127-185)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(15127-185)