Active Ingredient
Acetaminophen, 160mg
Novalgina Acetaminophen Pain And Fever For Childrens
FDA Label NDC 83057-0003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hbc Pharma, Llc for the product Novalgina Acetaminophen Pain And Fever For Childrens (NDC 83057-0003). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if your child, ask a doctor or pharmacist before use if your, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
temporarily:
■ reduces fever
■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount for this product
■ with other drugs containing acetaminophen.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning: if sore throat is severe, persistent for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. Consult a doctor promptly.
Do Not Use
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask A Doctor Before Use If Your Child
has liver disease
Ask A Doctor Or Pharmacist Before Use If Your
child is taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
■ pain gets worse or lasts more than 5 days ■ 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.
Keep Out Of Reach Of Children.
Overdose warning in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222- 1222)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222- 1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Do not give more than directed, this product does not contain directions or complete warnings for adult use, find right dose on
chart below. If possible, use weight to dose; otherwise, use age. Repeat dose every 4 hours while symptoms last, do not give more than 5 times in 24 hours. Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| Weight (lbs) | Age (Years) | Dose |
| under 24 lbs. | under 2 years | Ask a doctor |
| 24-35 lbs. | 2 - 3 years | 5 mL |
| 36-47 lbs. | 4-5 years | 7.5 |
| 48-59 lbs. | 6-10 Years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 72-95 lbs | 11 years | 15 ml |
Other Information
■ Store between 20-25°C (68-77°F)
■ Don’t use if carton tape or bottle wrap imprinted with is broken or missing
Inactive Ingredient
Citric acid, corn syrup, FD&C red no. 40, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben,
purified water, sodium citrate, sorbitol solution, natural and artificial strawberry flavor, sucralose.
Questions Or Comments?
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