Label: CURANOL- acetaminophen suspension
- NDC Code(s): 83335-104-04, 83335-104-08, 83335-104-16
- Packager: Wittman Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 18, 2024
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- Official Label (Printer Friendly)
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DOSAGE & ADMINISTRATION
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 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
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
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CURANOL
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83335-104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83335-104-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2023 2 NDC:83335-104-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2023 3 NDC:83335-104-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/01/2023 Labeler - Wittman Pharma, Inc. (830980947) Establishment Name Address ID/FEI Business Operations Wittman Pharma, Inc. 830980947 label(83335-104) , manufacture(83335-104) , analysis(83335-104)
