ACETAMINOPHEN JUNIOR- acetaminophen tablet, chewable
WinCo Foods, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Winco 44-449-delisted

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
- headache
- flu
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 (1-800-222-1222) 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
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
if needed, repeat dose every 4 hours while symptoms last
dissolve in mouth or chew before swallowing
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 48	Under 6	Ask a doctor
48-59	6-8	2
60-71	9-10	2 1/2
72-95	11	3

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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 to report a side effect call 800-824-1706 Monday - Friday 9am - 4pm MST

Principal Display Panel

*Compare to the active ingredient in Junior Strength TYLENOL® Meltaways®

WinCo™
FOODS

JUNIOR
Acetaminophen

PAIN RELIEVER - FEVER REDUCER

Ibuprofen Free, Aspirin Free

AGES
6-11

24
Tablets

160 mg EACH

Grape Flavored

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by MCNEIL CONSUMER HEALTHCARE, distributor of Junior Strength TYLENOL® Meltaways®.

The Supermarket Low Price Leader®

100% SATISFACTION GUARANTEE

Comments & Questions?
800-824-1706 • www.wincofoods.com

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

Winco 44-449

ACETAMINOPHEN JUNIOR
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67091-113
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTRATES (UNII: G263MI44RU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)

Product Characteristics
Color	PURPLE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	GRAPE	Imprint Code	44;449
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67091-113-24	4 in 1 CARTON	01/28/2005	02/13/2019
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	01/28/2005	02/13/2019

Labeler - WinCo Foods, LLC (056098817)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(67091-113)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(67091-113)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(67091-113)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(67091-113)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(67091-113)

Revised: 1/2018

Document Id: 010b342f-a929-4d62-90ae-493ebf8b3b4d

Set id: 2ea2ddd1-f246-4969-a4fc-6165c311c093

Version: 5

Effective Time: 20180116

WinCo Foods, LLC