Acetaminophen Solution
FDA Label NDC 60687-751

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Acetaminophen (NDC 60687-751). 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 purpose, active ingredient(in each 10.15 ml cup), uses, liver warning:, allergy alert:, sore throat warning:, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • adult takes more than 10 unit dose cups in 24 hours, which is the maximum daily amount
  • child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are allergic to acetaminophen or any of the inactive ingredients of this product

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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 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. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • agedose

    adults and children 12 years of age and over

    20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period

    children 6 to under 12 years of age

    10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period

    children under 6 years of age

    consult a doctor

Other Information

  • Each 10.15 mL contains: sodium 4 mg
  • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  • protect from light
  • a red, cherry flavored solution supplied in the following oral dosage forms:
    10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56

Inactive Ingredients:

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions Or Comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Other

DO NOT USE IF SEAL IS BROKEN.

Distributed by:
American Health Packaging
Columbus, OH 43217

R03/23

Principal Display Panel – Tray Label

Tray Label (Label)

Tray Label (Label)

Case NDC 60687-751-56/Cup NDC 60687-751-42

ACETAMINOPHEN
ORAL SOLUTION USP

325 mg/10.15 mL

ALCOHOL FREE

Each 10.15 mL contains:
Acetaminophen      325 mg

USUAL DOSAGE:See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].

For Institutional Use Only.

T0657C110323              R03/23

Principal Display Panel – Cup – 325 Mg / 10.15 Ml

325 mg/10.15 mL Acetaminophen Oral Solution Cup (Cup)

325 mg/10.15 mL Acetaminophen Oral Solution Cup (Cup)

NDC 60687- 751-42

ACETAMINOPHEN
ORAL SOLUTION USP

Pain Reliever/Fever Reducer

325 mg/10.15 mL

ALCOHOL FREE

Delivers 10.15 mL

Protect from light.

See packaging Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0657C110323

* Please review the disclaimer below.