FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Oncor Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
Tamper-Evident:
Do not use if foil seal over bottle opening is torn, broken, or missing.
Active Ingredient (In Each 5 Ml Teaspoonful)
Acetaminophen, USP 160 mg
Purpose
Pain reliever/Fever reducer
Uses
For the temporary relief of minor aches and pains associated with:
• the common cold
• flu
• sore throat
• headache
• toothache
• and to reduce fever
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 useif your child has liver disease.
Ask a doctor or pharmacist before useif 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.
Otc - Keep Out Of Reach Of Children
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.
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
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)
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.
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.
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
* Please review the disclaimer below.