FDA.reportPublic FDA data

ACETAMINOPHEN

Manufacturer
ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS
Effective date
2022-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:32

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

To reduce fever and for the temporary relief of 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

shake well before using find the right dose on chart below, if possible, use weight to dose; otherwise use age dosage may be repeated every 4 hours, or as directed by your doctor do not use more than 5 doses in 24 hours do not use more than 5 days unless directed by a doctor. find right dose on chart below, If possible, use weight to dose; otherwise, use age. Weight (lbs.)           Age (years)              dosage...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL = 1 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

To reduce fever and for the temporary relief of 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

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses 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.

Sore throat warning:

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non-prescription). 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has

  • liver disease
  • is on a sodium-restricted diet.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product: Do not exceed recommended dose

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning:

OVERDOSAGE SECTION

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/children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • find the right dose on chart below, if possible, use weight to dose; otherwise use age
  • dosage may be repeated every 4 hours, or as directed by your doctor
  • do not use more than 5 doses in 24 hours
  • do not use more than 5 days unless directed by a doctor.
  • find right dose on chart below, If possible, use weight to dose; otherwise, use age.
Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.)
 under 24 under 2 consult Physician
 24 to 35 2 to 3 1 tsp. (5 mL)
 36 to 47 4 to 5 1 1/2 tsp. (7.5 mL)
 48 to 59 6 to 8 2 tsp. (10 mL)
 60 to 71 9 to 10 2 1/2 tsp. (12.5 mL)
 72 to 95 11 3 tsp. (15 mL)

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 15°-30° C (59°-86°F)
  • Protect from Freezing. 
  • Protect from Light.

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Bubble Gum Flavor, Citric Acid, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN3
307675acetaminophen 32 MG/ML Oral SolutionSCD3
307675acetaminophen 160 MG per 5 ML Oral SolutionSY3
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY3
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY3
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY3
307675APAP 32 MG/ML Oral SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0182-32024-01-30C16284748780-11030e364-fb3f-111a-e063-dadaa90a10e2Acetaminophen Elxir Bubble Gum Flavor
17856-0182-42024-01-30C16284748780-11030e364-fb3f-111a-e063-dadaa90a10e2Acetaminophen Elxir Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0182-1ACETAMINOPHEN120 in 1 BOX, UNIT-DOSEELIXIR1203
17856-0182-2ACETAMINOPHEN2 mL in 1 SYRINGEELIXIR23
17856-0182-3ACETAMINOPHEN5 in 1 SYRINGEELIXIR53
17856-0182-4ACETAMINOPHEN72 in 1 BOX, UNIT-DOSEELIXIR723
17856-0182-5ACETAMINOPHEN5 mL in 1 CUP, UNIT-DOSEELIXIR53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0182ACETAMINOPHEN ELIXIR [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 5 package rows20221115_cf2dd95d-afea-462d-9dba-a46a68bf67e6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0182-4ML - Milliliter17856-0182095990e2-50ba-4bb4-a465-af7821d7ccb312023-06-06
71399-0160-6ML - Milliliter71399-01600aedb9a5-cddb-4bc5-989c-533f4ac4b85a12023-03-13

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
17856-018217856-0182-2, 17856-0182-1, 17856-0182-3, 17856-0182-5, 17856-0182-4
71399-0160

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
ACETAMINOPHEN362O9ITL9DACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d19a5550-893e-414a-b725-f326cfd635cccf2dd95d-afea-462d-9dba-a46a68bf67e62022-11-14WarningsExact identifier
spl id: d19a5550-893e-414a-b725-f326cfd635cc
spl set id: cf2dd95d-afea-462d-9dba-a46a68bf67e6

Reported adverse events (FAERS/openFDA)#

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