OTC Medication Information: Acetaminophen Junior

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.

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27
D&C RED NO. 30
DEXTRATES
FD&C BLUE NO. 1
MAGNESIUM STEARATE
MANNITOL
STEARIC ACID
SUCRALOSE
ETHYLCELLULOSES
Product Characteristics
Color PURPLE Score 2 pieces
Shape ROUND Size 16mm
Flavor GRAPE Imprint Code 44;449
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67091-113-24 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (67091-113-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/28/2005 02/13/2019
Labeler — WinCo Foods, LLC (056098817)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (67091-113)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE (67091-113)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 PACK (67091-113)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (67091-113)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 PACK (67091-113)

Revised: 01/2018 WinCo Foods, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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