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| Product NDC Code | 83720-500 | ||||
|---|---|---|---|---|---|
| Drug Name | Acetaminophen |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 307675 | ||||
| Application Number | M013 | ||||
| Labeler Name | Oncor Pharmaceuticals | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL teaspoonful) Acetaminophen, USP 160 mg
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 this product does not contain directions or complete warnings for adult use Use only the enclosed dosing cup designed for use with this product. if possible, use weight to dose, otherwise use age. dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor. Weight (lbs.) Age (years) Dosage Teaspoonful (tsp)* Under 24 Under 2 Consult a doctor 24 to 35 2 to under 4 5 mL (1 tsp) 36 to 47 4 to under 6 7.5 mL (1 1/2 tsp) 48 to 59 6 to under 9 10 mL (2 tsp) 60 to 71 9 to under 11 12.5 mL (2 1/2 tsp) 72 to 95 11 to under 12 15 mL (3 tsp) * or as directed by a doctor
| Under 24 | Under 2 | Consult a doctor |
| 24 to 35 | 2 to under 4 | 5 mL (1 tsp) |
| 36 to 47 | 4 to under 6 | 7.5 mL (1 1/2 tsp) |
| 48 to 59 | 6 to under 9 | 10 mL (2 tsp) |
| 60 to 71 | 9 to under 11 | 12.5 mL (2 1/2 tsp) |
| 72 to 95 | 11 to under 12 | 15 mL (3 tsp) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, 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 For the temporary relief of minor aches and pains associated with: • the common cold • flu • sore throat • headache • toothache • and to reduce 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.Acetaminophen Acetaminophen CITRIC ACID MONOHYDRATE FD&C RED NO. 40 POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM ACETAMINOPHEN ACETAMINOPHEN
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.PRINCIPAL DISPLAY PANEL ONCOR PHARMACEUTICALS NDC 83720- 500 -16 Pain and Fever Relief kids Acetaminophen Liquid 160 mg / 5 mL Alcohol Free Sugar Free Aspirin Free Ibuprofen Free Cherry Flavor 16 fl. oz. - 473 mL acetaminophen-16
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Tamper-Evident: Do not use if foil seal over bottle opening is torn, broken, or missing.
Manufactured in USA for: Oncor Pharmaceuticals Columbia MD 21045 Rev. 01/2024 MADE IN USA
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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.
Storage and handling
Information about safe storage and handling of the drug product.Other information Each 5 mL contains: Sodium 3 mg If dispensed, dispense in a tight, light resistant container with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
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 your child takes: • more than 5 doses in 24 hours, which is the maximum daily amount • 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, persists 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. 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 pain gets worse or lasts more than 5 day. fever gets worse or lasts more than 3 days redness or swelling is present. any new symotom appear. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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