Acetaminophen
FDA Label NDC 54868-1791

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Acetaminophen (NDC 54868-1791). 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, uses, sore throat warning:, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdose warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Uses

for the temporary relief of minor aches and pains associated with

  • a cold or flu
  • sore throat
  • headache
  • toothache
  • temporarily reduces fever

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 product containing acetaminophen
  • more than directed (see overdose warning)

Otc - Ask Doctor

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts more than 3 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • find right dose on chart
  • if possible, use weight to dose; otherwise, use age
  • if needed, repeat dose every 4 hours
  • do not use more than 5 times in 24 hours
    • WeightAgeDose
    under 24 lbsunder 2 yearsask a doctor
    24 to 35 lbs2 to 3 years1 teaspoon (5 mL)
    36 to 47 lbs4 to 5 years1 ½ teaspoons (7.5 mL)
    48 to 59 lbs6 to 8 years2 teaspoons (10 mL)
    60 to 71 lbs9 to 10 years2 ½ teaspoons (12.5 mL)
    72 to 95 lbs11 years3 teaspoons (15 mL)

Other Information

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

artificial cherry flavor, benzoic acid, citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Questions?

Call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

Principal Display Panel

ACETAMINOPHEN

ORAL SOLUTION USP

160 mg/5 mL

PAIN RELIEVER - FEVER REDUCER

Alcohol-Free
Aspirin-Free
Saccharin-Free
Cherry-Flavored

EACH TEASPOON (5 mL) CONTAINS:
Acetaminophen USP            160 mg

TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN

Distributed by:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
Dist. 1990 0809REV 71

Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

NDC 54868-1791-0
TAMPER-EVIDENT

ONE PINT (473 mL)

* Please review the disclaimer below.