Acetaminophen Liquid
FDA Label NDC 83720-500

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncor Pharmaceuticals for the product Acetaminophen (NDC 83720-500). 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 other, active ingredient (in each 5 ml teaspoonful), purpose, uses, warnings:, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

Acetaminophen-16 (Acetaminophen 16)

Acetaminophen-16 (Acetaminophen 16)

* Please review the disclaimer below.