The following Structured Product Label (SPL) was submitted to the FDA by Wittman Pharma, Inc. for the product Curanol (NDC 83335-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
| Weight (lbs) | Under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 | Over 95 |
| Age (years) | Under 2 | 2 to 3 | 4 to5 | 6 to 8 | 9 to 10 | 11 | 12 to Adult |
| Dosage Teaspoonful (tsp) | consult a doctor | 1 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, Xanthan Gum
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
Drug Facts
Active Ingredient (in each 5 mL tsp) Purpose
Acetaminophen,160mg Pain reliever/Fever reducer
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.
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.
Keep out of reach of children.
Drug Facts (continued)
In case of overdose, get medical help or contact a Poison Control Center
{1-800-222-1222) right away. Quick medical attention is critical for
adults/children even if you do not notice any signs or symptoms.
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
Other information
■ Store at controlled room temperature 15°-30°C (59°-86°F). Do not refrigerate
■ Protect from light. Avoid excessive heat or humidity.
Inactive ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium
Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol,
Sucralose, Xanthan Gum
Questions? Call 1-362-549-9917 M-F 9am - 5pm EST
Manufactured for: Wittman Pharma, Inc. Brooksville, FL 34604
'This product is not manufactured or distributed by McNeil Consumer Healthcare,
Distributor of Tylenol Liquid. Rev.12/2023
Label (Curanol.jpg)
* Please review the disclaimer below.
