CuraNOL

Manufacturer
Wittman Pharma, Inc.
Effective date
2024-04-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:11:13

Label at a glance#

ProductCuraNOL
Active ingredientACETAMINOPHEN
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions:

■ Dosage may be repeated every 4 hours, or as directed by doctor

■ Do not exceed recommended dose.

■ Find dose in chart below ■ If possible, use weight to dose, otherwise use age

Dosage
Weight (lbs)Under 2424-3536-4748-5960-7172-95Over 95
Age (years)Under 22 to 34 to56 to 89 to 101112 to Adult
Dosage Teaspoonful (tsp)consult a doctor1 tsp (5 mL)1 1/2 tsp (7.5 mL)2 tsp (10mL)2 1/2 tsp (12.5 mL)3 tsp (15 mL)4 tsp (20mL)

WARNINGS SECTION

Warnings: Liver Warning: This product contains acetaminophen.

Severe liver damage may occur if.

■ adults take more than 6 doses in 24 hours, which is the maximum daily amount

■ child takes more than 5 doses in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen (prescription or nonprescription)

■ adult has 3 or more alcoholic drinks while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may

include: ■ skin reddening ■ blisters ■rash

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

Do not use with any other product containing acetaminophen (prescription or

nonprescription), this will provide more than the recommended dose (overdose)

of acetaminophen and could cause serious health concerns. If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

WHEN USING THIS PRODUCT, DO NOT EXCEED RECOMMENDED DOSE

Ask a doctor before use if you have a liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask doctor if: ■ pain gets worse or lasts more than 10 days in adults

■ pain gets worse or lasts more than 5 days in children under 12 years

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

If pregnant or breast-feeding, ask a health professional before use.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol,

Sucralose

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves minor aches and pains due to: ■ headache

■ backache ■ muscular aches ■ minor pain of arthritis ■ the common cold

■ toothache ■ premenstrual and menstrual cramps

Temporarily reduces fever.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Purpose:

Pain reliever/Fever reducer

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 mL tsp)

Acetaminophen,160mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CuraNOL LabelCuraNOL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN4
307668acetaminophen 32 MG/ML Oral SuspensionSCD4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY4
307668APAP 32 MG/ML Oral SuspensionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83335-104-042025-07-29C16284748780-13b156c62-3235-fb37-e063-e6dba90a4e07CuraNOL
83335-104-082025-07-29C16284748780-13b156c62-3235-fb37-e063-e6dba90a4e07CuraNOL
83335-104-162025-07-29C16284748780-13b156c62-3235-fb37-e063-e6dba90a4e07CuraNOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83335-104-04CuraNOL118 mL in 1 BOTTLE, PLASTICSUSPENSION1184
83335-104-08CuraNOL237 mL in 1 BOTTLE, PLASTICSUSPENSION2374
83335-104-16CuraNOL473 mL in 1 BOTTLE, PLASTICSUSPENSION4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83335-104CURANOL (ACETAMINOPHEN) SUSPENSION [WITTMAN PHARMA, INC.]43 package rows20240420_0ce0f4af-da22-7a3d-e063-6394a90a2321.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83335-10483335-104-16, 83335-104-08, 83335-104-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
166341fd-c187-b351-e063-6394a90aa2880ce0f4af-da22-7a3d-e063-6394a90a23212024-04-18WarningsExact identifier
spl id: 166341fd-c187-b351-e063-6394a90aa288
spl set id: 0ce0f4af-da22-7a3d-e063-6394a90a2321

Reported adverse events (FAERS/openFDA)#

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