CURANOL- acetaminophen suspension 
Wittman Pharma, Inc.

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CuraNOL

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: 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 ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium

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

Sucralose

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.

Keep out of reach of children.

Purpose:

Pain reliever/Fever reducer

Active Ingredient (in each 5 mL tsp)

Acetaminophen,160mg

CuraNOL Label

CURANOL 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83335-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83335-104-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
2NDC:83335-104-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
3NDC:83335-104-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/01/2023
Labeler - Wittman Pharma, Inc. (830980947)
Establishment
NameAddressID/FEIBusiness Operations
Wittman Pharma, Inc.830980947label(83335-104) , manufacture(83335-104) , analysis(83335-104)

Revised: 4/2024
Document Id: 166341fd-c187-b351-e063-6394a90aa288
Set id: 0ce0f4af-da22-7a3d-e063-6394a90a2321
Version: 4
Effective Time: 20240418
 
Wittman Pharma, Inc.