FDA.reportPublic FDA data

Llorens Care Children Acetaminophen

Manufacturer
Llorens Pharmaceutical International Division, Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:30:03

Label at a glance#

ProductLlorens Care Children Acetaminophen
Active ingredientACETAMINOPHEN
Label structure8 sections

Dosage and administration

do not give more than directed shake well before using this product does not contain directions or complete warnings for adult use find dose in chart below; if possible, use weight to dose, otherwise use age dosage may be repeated every 4 hours, or as directed by a doctor do not give more than 5 times in 24 hours Weight (lbs) under 24 24-35 36-47 48-59 60-71 72-95 over 95 Age (years) under 2 2 to 3 4 to 5 6 to 8 9...

Label contents#

Full prescribing information#

Active ingredient (in each 5mL = 1 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever / Fever Reducer

INDICATIONS & USAGE SECTION

Uses

  • temporarily reduces fever
  • temporarilty relieves minor aches and pains due to:
  • headache
  • sore throat
  • the common cold
  • 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.

Allergy Alert:

acetaminophen may cause sever skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

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

When using this product: Do not exceed recommended dose.

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.

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.

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give more than directed
  • shake well before using
  • this product does not contain directions or complete warnings for adult use
  • find dose in chart below; if possible, use weight to dose, otherwise use age
  • dosage may be repeated every 4 hours, or as directed by a doctor
  • do not give more than 5 times in 24 hours
Weight (lbs)under 2424-3536-4748-5960-7172-95over 95
Age (years)under 22 to 34 to 56 to 89 to 101112 to adult
Dosage Teaspoonful (tsp)consult physician1 tsp (5 mL)1 1/2 tsp (7.5 mL)2 tsp (10 mL)2 1/2 tsp (12.5 mL)3 tsp (15 mL)4 tsp (20 (mL)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artifical and natural grap flavor, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium, potassium sorbate, purified water, sorbitol solution, sucralose, and xanthan gum

QUESTIONS? COMMENTS?

OTC - QUESTIONS SECTION

Call 1-866-595-5598

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lolapaplolapap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN2
307668acetaminophen 32 MG/ML Oral SuspensionSCD2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY2
307668APAP 32 MG/ML Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-850-04Llorens Care Children Acetaminophen118 mL in 1 BOTTLESUSPENSION1182
54859-850-16Llorens Care Children Acetaminophen473 mL in 1 BOTTLE, PLASTICSUSPENSION4732

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
54859-85054859-850-16, 54859-850-04

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
SUCROSEC151H8M554IACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT

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
Llorens Care Children AcetaminophenACETAMINOPHENLlorens Pharmaceutical International Division, Inc.2a46d7d2-293b-5024-e063-6294a90a31aa2025-12-31WarningsExact identifier
ndc (package): 54859-850-04
ndc (package): 54859-850-16
ndc (product): 54859-850
ndc11 (package): 54859085016
ndc11 (package): 54859085004
spl id: 47461076-1bb3-ffd6-e063-6294a90a5885
spl set id: 2a46d7d2-293b-5024-e063-6294a90a31aa

Reported adverse events (FAERS/openFDA)#

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