FDA.reportPublic FDA data

Pediacare Childrens Acetaminophen Grape

Manufacturer
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:56

Label at a glance#

ProductPediacare Childrens Acetaminophen Grape
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. Shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. only use enclosed measuring syringe repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by doctor under 24 under 2 yr ask a doctor 24...

Storage and handling

Store between 15° - 30° C (59° - 86° F) Protect from Freezing Protect from Light

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non-prescription). 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child hasliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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 1-800-222-1222. Quick medical attention is critical for adults as well as for children 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.
  • Shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use enclosed measuring syringe
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL) *
under 24under 2 yrask a doctor
24-352-3 yr5 mL

* or as directed by doctor

Other information

STORAGE AND HANDLING SECTION

  • Store between 15° - 30° C (59° - 86° F)
  • Protect from Freezing
  • Protect from Light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, citric acid, corn syrup, FD&C blue #1, FD&C red #33 flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

SPL UNCLASSIFIED SECTION

Distributed by
CrossingWell
Consumer Health
PO Box 440
Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fast Acting
Pedia
Care ®
100% dedicated
to kids™

Infants

ACETAMINOPHEN

Pain Reliever/
Fever Reducer

Acetaminophen (160 mg per 5mL)
Oral Suspension

Alcohol Free, Asprin Free
Ibuprofen Free, No Parabens

Grape Flavor
(Use Only Enclosed Syringe)

1 FL OZ (30mL)
160 mg per 5 mL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN3
307668acetaminophen 32 MG/ML Oral SuspensionSCD3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY3
307668APAP 32 MG/ML Oral SuspensionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-906-01Pediacare Childrens Acetaminophen Grape1 in 1 CARTONSUSPENSION13
52412-906-01Pediacare Childrens Acetaminophen Grape30 mL in 1 BOTTLESUSPENSION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-906PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE (ACETAMINOPHEN) SUSPENSION [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH]3Current NDC, Legacy NDC, 2 package rows20250101_596372c7-eca3-4527-8e22-ab0751e2526b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52412-90652412-906-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CORN SYRUP9G5L16BK6NIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
Pediacare Childrens Acetaminophen GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH596372c7-eca3-4527-8e22-ab0751e2526b2024-12-30WarningsExact identifier
ndc (package): 52412-906-01
ndc (product): 52412-906
ndc11 (package): 52412090601
spl id: 2a812e53-97e7-9d66-e063-6394a90a72a2
spl set id: 596372c7-eca3-4527-8e22-ab0751e2526b

Reported adverse events (FAERS/openFDA)#

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