Acetaminophen Liquid
FDA Label NDC 69367-323

17 label sections · Submitted to the FDA by Westminster Pharmaceuticals, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Acetaminophen (NDC 69367-323). 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, liver warning, allergy alert, sore throat warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

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

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 that contain 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.

Otc - Do Not Use

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.

Otc - Ask Doctor

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
  • redness or swelling is present
  • any new symptoms 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)

    or as directed by a doctor

    Under 24Under 2Consult a doctor
    24 to 352 to under 45 mL (1 tsp)
    36 to 474 to under 67.5 mL (1 1/2 tsp)
    48 to 596 to under 910 mL (2 tsp)
    60 to 719 to under 1112.5 mL (2 1/2 tsp)
    72 to 9511 to under 1215 mL (3 tsp)

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 Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088.

Principal Display Panel - 118 Ml Bottle Label

NDC 69367-323-04

Children's
Acetaminophen
Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer
Sugar Free / Alcohol Free
Aspirin Free
CHERRY FLAVOR

4 fl. oz. (118 mL)

Westminster
Pharmaceuticals

Principal Display Panel (118 mL Bottle Label)

Principal Display Panel (118 mL Bottle Label)

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