ACETAMINOPHEN JUNIOR STRENGTH- acetaminophen tablet, chewable

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • sore throat
  • flu
  • headache
• 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 the 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 48	Under 6	Ask a doctor
48-59	6-8	2
60-71	9-10	2 1/2
72-95	11	3

*or as directed by a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• see end flap for expiration date and lot number
• avoid high humidity

Inactive ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Principal Display Panel

EQUALINE®

compare to
Junior Strength
Tylenol® Meltaways® 
active ingredients**

NDC: 41163-450-08

junior strength
acetaminophen
160mg, rapid tabs
pain reliever/fever reducer

for ages 6-11
bubble gum flavor

fast dissolving
 aspirin free
ibuprofen free

24 rapid tablets

actual size

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

DOES NOT CONTAIN GLUTEN

** This product is not manufactured or distributed by McNeil Consumer Healthcare,
owner of the registered trademark Junior Strength Tylenol® Meltaways®.

50844    REV1013G45008

We're committed to your
satisfaction and guarantee
the quality of this product.
Contact us at 1-877-932-7948, or
www.supervalu-ourownbrands.com.
Please have package available.

DISTRIBUTED BY SUPERVALU INC.
EDEN PRARITE, MN 55344 USA

Equaline 44-450

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  JUNIOR STRENGTH
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-450
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)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CROSPOVIDONE (UNII: 2S7830E561)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	BUBBLE GUM	Imprint Code	44;450
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-450-08	4 in 1 CARTON	02/25/2005	08/10/2020
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 NOT FINAL	part343	02/25/2005	08/10/2020

Labeler - SUPERVALU INC. (006961411)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(41163-450)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(41163-450)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(41163-450)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(41163-450)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(41163-450)