Childrens Acetaminophen Suspension
FDA Label NDC 55154-5787

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Childrens Acetaminophen (NDC 55154-5787). 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, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

When using this product, do not exceed the recommended dose (see overdose warning)

Pharmaceutical
Associates, Inc.

Greenville, SC 29605
www.paipharma.com

Distributed by:

Cardinal Health

Dublin, OH 43017

L55345730519

R01/17

Active Ingredient (In Each 5 Ml Teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily:

  • reduces fever
  • relieves minor aches and pain due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

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.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease.

Otc - Ask Doctor/Pharmacist

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.

Otc - Keep Out Of Reach Of Children

Keep out of the 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 children even if you do not notice any sign or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter; tsp = teaspoonful
  • find the 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

    • Weight (lbs)

    Age (yr)

    Dose (mL or tsp)

    or as directed by a doctor

    Under 24

     Under 2

     Ask a doctor

    24-35

    2-3 years

    5 mL (1 tsp)

    36-47

    4-5 years

    7.5 mL (1 ½ tsp)

    48-59

    6-8 years

     10 mL (2 tsp)

    60-71

    9-10 years

    12.5 mL (2 ½ tsp)

    72-95

    11 years

    15 mL (3 tsp)

Other Information

  • sodium content: 2 mg/5 mL 
  • store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
  • protect from freezing
  • a red, berry flavored suspension supplied in the following oral dosage form:

    • .

    Overbagged with 5 - (5 mL unit dose cups) per bag, NDC 55154-5787-5

Inactive Ingredients

Acesulfame K, butylparaben, citric acid, corn syrup, FD&C Red No. 40, flavoring, glycerin, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

Principal Display Panel

Children’s Acetaminophen

Oral Solution 160 mg/5 mL

5 Cups

* Please review the disclaimer below.