Acetaminophen Tablet
FDA Label NDC 58602-774

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Acetaminophen (NDC 58602-774). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each chewable tablet)


Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • soar throat
    • toothache
    • temporarily reduces 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.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

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
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition.

Keep Out Of 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 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.
  • do not give more than directed (see overdose warning)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find 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 (lb)
    		Age (yr)
    		Dose (tablets)*
    under 24
    		under 2 years
    		ask a doctor
    24 to 35 lbs
    		2 to 3 years
    		1 tablet
    36 to 47 lbs
    		4 to 5 years
    		1½ tablets
    48 to 59 lbs
    		6 to 8 years
    		2 tablets
    60 to 71 lbs
    		9 to 10 years
    		2½ tablets
    72 to 95 lbs
    		11 years
    		3 tablets

    * or as directed by a doctor

Other Information

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
  • do not use if carton is open or if printed seal on blister is broken or missing.

Inactive Ingredients

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.

Questions Or Comments?

Call 1-855-274-4122

Package Label-Principal Display Panel 160 Mg (48 Chewable Tablets Blister Carton Label)

Healthy LivingTM
Ages 2-11               DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

CHILDREN’S PAIN RELIEF
acetaminophen chewable tablets 160 mg

Pain Reliever / Fever Reducer

160 mg
per Tablet

Pain + Fever

Chewables - Chew or crush
tablets completely before swallowing

Compare
to the active
ingredient in
Children's
Tylenol®
Chewables

• Aspirin Free              
• Ibuprofen Free

Bubble Gum Flavor                            Actual Size
                                                   48 Chewable Tablets
                                                      160 mg each




Package Label-principal Display Panel 160 mg (24 Chewable Tablets Bottle Carton Label) (Acetaminophen Fig1)

Package Label-principal Display Panel 160 mg (24 Chewable Tablets Bottle Carton Label) (Acetaminophen Fig1)

* Please review the disclaimer below.