Acetaminophen

Manufacturer
Safecor Health, LLC
Effective date
2022-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:42:41

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure15 sections

Indications and uses

Temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

Do not take more than directed Find dose in chart below If possible, use weight to dose, otherwise use age Dosage may be repeated every 4 hours, or as directed by a doctor Do not give more than 5 doses in 24 hours  Weight (lbs) Under 24  24-35  36-47 48-59   60-71  72-95  over 95 Age (years)  Under 2  2 to 3  4 to 5  6 to 8  9 to 10  11  12 to adult Dosage mL (tsp)  Consult Physician 5 mL (1 tsp ) 7.5 mL (1 1/2 ts...

Storage and handling

Store at room temperature 15°C- 30°C (59°F-86°F) Protect from freezing Protect from light Aspirin Free Alcohol Free TAMPER-EVIDENT : Do not use if foil seal over syringe blister is torn, broken, or missing or if endcap is broken, missing, or separated from syringe. For more info call 1-800-447-1006

Label contents#

Full prescribing information#

Active Ingredient (per 5 mL = 1 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever / Fever Reducer

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings:

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:

  • more than 5 doses is taken in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday 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.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a liver disease.

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than directed
  • Find dose in chart below
  • If possible, use weight to dose, otherwise use age
  • Dosage may be repeated every 4 hours, or as directed by a doctor
  • Do not give more than 5 doses in 24 hours
 Weight (lbs)Under 24 24-35 36-4748-59  60-71 72-95 over 95
Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult
Dosage mL (tsp) Consult Physician5 mL (1 tsp )7.5 mL (1 1/2 tsp)10 mL (2 tsp)12.5 mL (2 1/2 tsp)15 mL (3 tsp)20 mL (4 tsp)

Other Information:

STORAGE AND HANDLING SECTION

  • Store at room temperature 15°C- 30°C (59°F-86°F)
  • Protect from freezing
  • Protect from light
  • Aspirin Free
  • Alcohol Free
  • TAMPER-EVIDENT: Do not use if foil seal over syringe blister is torn, broken, or missing or if endcap is broken, missing, or separated from syringe.
  • For more info call 1-800-447-1006

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

SPL UNCLASSIFIED SECTION

NDC: 48433-401-05 Acetaminophen Oral Liquid Unit Dose Oral ENFit® Syringe (160 mg / 5 mL)
NDC: 48433-401-25 Box of 25 Unit-Dose Oral ENFit® Syringes, each unit-dose syringe delivers 5 mL

For Oral Use Only.
For Institutional Use Only.
This Package Is Not Child Resistant.

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204                                                  Rev: 07/2022 PN5727

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFECOR HEALTH

NDC 48433-401-05

Acetominophen Oral Liquid

160 mg / 5 mL

(Delivers 5 mL)

image description
image description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-401-05ML - Milliliter48433-40107e714be-a927-4727-85fc-c7d9c8fbd2e712023-02-06
48433-401-25ML - Milliliter48433-4011524483b-c06c-4206-8c82-2303e174544f12023-02-06
54859-809-16ML - Milliliter54859-809a7cc10e7-86b4-485c-901e-bc571c0f4d1112020-01-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48433-40148433-401-05, 48433-401-25
54859-809

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liquid AcetaminophenACETAMINOPHENLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONa7dbd4c0-53eb-4368-917b-1432c09ce6b42025-12-31WarningsExact identifier
ndc (product): 54859-809
2ea7a853-6c44-4717-b75b-4086596d8fd4eab49198-9e9f-4d2e-b029-9e79bd14de0a2024-10-02WarningsExact identifier
spl set id: eab49198-9e9f-4d2e-b029-9e79bd14de0a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.