Acetaminophen Suspension
FDA Label NDC 68094-042

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose, Inc. for the product Acetaminophen (NDC 68094-042). 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), 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.

Other

Grape Flavor

80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL
650 mg/20.3 mL

For Hospital Use Only

LI1650 Rev. 10/24

Drug Facts

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

LI1650 Rev. 10/24

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken 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.
  • if your child has ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

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

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.

    • do not give this product to children for pain of arthritis unless directed by a doctor

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

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

  • Use as directed per healthcare professional.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • 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 take more than 5 times in 24 hours
  • Weight (lb)Age (yr)Dose (mL)

    or as directed by a doctor

    under 24under 2 yearsask a doctor
    24-352-3 years5 mL
    36-474-5 years7.5 mL
    48-596-8 years10 mL
    60-719-10 years12.5 mL
    72-9511 years15 mL
    Over 96Adults and children 12 years and over20 mL

Other Information

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions Or Comments?

1-800-397-9228

How Supplied

NDC 68094-042-58
2.5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper

NDC 68094-038-58
5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper

NDC 68094-130-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-231-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-330-61
10.15 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-330-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-030-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper

Principal Display Panel - 2.5 Ml Syringe Label

ACETAMINOPHEN ORAL SUSPENSION

80 mg / 2.5 mL
Delivers 2.5 mL

Store at 20-25°C (68-77°F)

Hospital Use Only • Alcohol Free

Aspirin Free • Gluten Free • Ibuprofen Free

For Oral Use Only

Pkg: Precision Dose, Inc. S. Beloit, IL 61080

Principal Display Panel (2.5 mL Syringe Label)

Principal Display Panel (2.5 mL Syringe Label)

* Please review the disclaimer below.