FDA.reportPublic FDA data

up and up juniors acetaminophen

Manufacturer
Target Corporation
Effective date
2015-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:19

Label at a glance#

Productup and up juniors acetaminophen
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

• temporarily relieves minor aches and pains due to: • the common cold • flu • headache • temporarily reduces fever

Dosage and administration

• this product does not contain directions or complete warnings for adult use. • do not give more than directed (see overdose warning) • find the right dose on chart below. If possible, use weight to dose; otherwise use age. • dissolve in mouth or chew before swallowing • if needed, 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 d...

Storage and handling

• store between 20º-25ºC (68º-77ºF). Avoid high humidity • see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • dissolve in mouth or chew before swallowing
  • if needed, 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)

under 48

48-59

60-71

72-95

96 and over

Age (yr)

under 6 years

6-8 years

 9-10 years

11 years

12 years

Tablets

 ask a doctor

 2

2 1/2

3

4

Other information

STORAGE AND HANDLING SECTION

  • store between 20º-25ºC (68º-77ºF). Avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, corn starch, crospovidone, D&C red no. 30 aluminum lake, dextrose, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-910-6874

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11673-160-32

Compare to active ingredient in Junior Strength Tylenol® Meltaways®*

Juniors’

acetaminophen

melty tabs,160 mg

pain reliever/fever reducer

aspirin-free

ibuprofen-free

AGES 6-11 YEARS

GRAPE FLAVOR

24 CHEWABLE TABLETS

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

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


50844 REV0213F44908

094 01 0603 R01 ID225450

Distributed by Target Corporation

Minneapolis,MN 55403

© 2014 Target Brands,Inc.

Shop Target.com

up and up juniors acetaminophen melty tabs grape flavor
up and up juniors acetaminophen melty tabs grape flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477282acetaminophen 160 MG Disintegrating Oral TabletPSN1
477282acetaminophen 160 MG Disintegrating Oral TabletSCD1
477282APAP 160 MG Disintegrating Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-160-322020-01-31C16284748780-19d75b9d0-a38d-f424-e053-dadaa90a57ceup and up juniors’ acetaminophen melty tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-160-32up and up juniors acetaminophen6 in 1 BLISTER PACKTABLET, CHEWABLE61
11673-160-32up and up juniors acetaminophen4 in 1 CARTONTABLET, CHEWABLE41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-160UP AND UP JUNIORS ACETAMINOPHEN (ACETAMINOPHEN) TABLET, CHEWABLE [TARGET CORPORATION]1Legacy NDC, 2 package rows20160304_72804e03-4043-4188-85ac-9272f13856a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-160-30EA - Each11673-160b98ece78-ddb0-467a-97a4-bca53e0cfda812013-08-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-16011673-160-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE68401960MKIACT
D&C RED NO. 302S42T2808BIACT
DEXTROSEIY9XDZ35W2IACT
ETHYLCELLULOSES7Z8S9VYZ4BIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
MALTODEXTRIN7CVR7L4A2DIACT
MAGNESIUM STEARATE70097M6I30IACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
72804e03-4043-4188-85ac-9272f13856a372804e03-4043-4188-85ac-9272f13856a32015-01-16WarningsExact identifier
spl id: 72804e03-4043-4188-85ac-9272f13856a3
spl set id: 72804e03-4043-4188-85ac-9272f13856a3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.