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| Product NDC Code | 83335-104 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Curanol |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | SUSPENSION | ||||||||
| RxCUI drug identifier | 307668 | ||||||||
| Application Number | M013 | ||||||||
| Labeler Name | Wittman Pharma, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each 5 mL tsp) Acetaminophen,160mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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)
| 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) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose: Pain reliever/Fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.CuraNOL Acetaminophen METHYLPARABEN POTASSIUM CITRATE PROPYLPARABEN SORBITOL PROPYLENE GLYCOL ACETAMINOPHEN ACETAMINOPHEN WATER SUCRALOSE AMMONIUM GLYCYRRHIZATE ANHYDROUS CITRIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.CuraNOL Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API