ACETAMINOPHEN

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2020-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:44

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-teaspoonfu...

Storage and handling

• Store at room temperature 15°-30° C (59°-86°F) • Protect from Freezing. • Protect from Light. TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

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

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:

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

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

  • 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

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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/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

STORAGE AND HANDLING SECTION

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

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Grape Flavor, Citric Acid, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

How Supplied:

17856-5401-01 ACETAMINOPHEN - 48MG/1.5ML SYRINGE 120 UD
17856-5401-02 ACETAMINOPHEN - 64MG/2ML SYRINGE 120 UD
17856-5401-03 ACETAMINOPHEN - 96MG/3ML SYIRNGE 120 UD
17856-5401-04 ACETAMINOPHEN - 3.75 ML SYRINGE 48 ct UD
17856-5401-05 ACETAMINOPHEN - 5 ML CUP 72 ct UD
17856-5401-06 ACETAMINOPHEN - 192MG/6ML SYRINGE 48 ct UD
17856-5401-07 ACETAMINOPHEN - 240MG/7.5ML SYRINGE 48 ct UD
17856-5401-08 ACETAMINOPHEN - 325MG/10.15 ML CUP 72 ct UD
17856-5401-09 ACETAMINOPHEN - 480MG/15ML 50 CUP ct UD

Questions or Comments?

OTC - QUESTIONS SECTION

Call (877) 225-6999 Monday - Friday 9AM-5PM EST

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

Manufactured In USA

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir

Distributed by:

ATLANTIC BIOLOGICALS CORP.

Miami, FL 33179

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

• Compare To Active ingredient of Children's Tylenol Elixir

Children's

Pain Relief

Pain Reliever and
Fever Reducer

Acetaminophen 160 mg per 5 ml Oral Elixir

• Alcohol Free

• Asprin Free

• For Ages 2 - 11 years

Grape Flavor

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN1
307675acetaminophen 32 MG/ML Oral SolutionSCD1
307675acetaminophen 160 MG per 5 ML Oral SolutionSY1
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY1
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY1
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY1
307675APAP 32 MG/ML Oral SolutionSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5401-1ACETAMINOPHEN1.5 mL in 1 SYRINGEELIXIR1.51
17856-5401-1ACETAMINOPHEN120 in 1 BOX, UNIT-DOSEELIXIR1201
17856-5401-2ACETAMINOPHEN120 in 1 BOX, UNIT-DOSEELIXIR1201
17856-5401-2ACETAMINOPHEN2 mL in 1 SYRINGEELIXIR21
17856-5401-3ACETAMINOPHEN3 mL in 1 SYRINGEELIXIR31
17856-5401-3ACETAMINOPHEN120 in 1 BOX, UNIT-DOSEELIXIR1201
17856-5401-4ACETAMINOPHEN48 in 1 BOX, UNIT-DOSEELIXIR481
17856-5401-4ACETAMINOPHEN3.75 mL in 1 SYRINGEELIXIR3.751
17856-5401-5ACETAMINOPHEN72 in 1 BOX, UNIT-DOSEELIXIR721
17856-5401-5ACETAMINOPHEN5 mL in 1 CUP, UNIT-DOSEELIXIR51
17856-5401-6ACETAMINOPHEN6 mL in 1 SYRINGEELIXIR61
17856-5401-6ACETAMINOPHEN48 in 1 BOX, UNIT-DOSEELIXIR481
17856-5401-7ACETAMINOPHEN7.5 mL in 1 SYRINGEELIXIR7.51
17856-5401-7ACETAMINOPHEN48 in 1 BOX, UNIT-DOSEELIXIR481
17856-5401-8ACETAMINOPHEN10.15 mL in 1 CUP, UNIT-DOSEELIXIR10.151
17856-5401-8ACETAMINOPHEN72 in 1 BOX, UNIT-DOSEELIXIR721
17856-5401-9ACETAMINOPHEN15 mL in 1 CUP, UNIT-DOSEELIXIR151
17856-5401-9ACETAMINOPHEN50 in 1 BOX, UNIT-DOSEELIXIR501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5401ACETAMINOPHEN ELIXIR [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 18 package rows20200903_e040616b-bdca-4f5d-9d43-6dc64dc425f1.zip

Products#

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NDC Codes#

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b17d8b01-e4bf-4730-b154-c7c0d363e95ae040616b-bdca-4f5d-9d43-6dc64dc425f12020-09-02WarningsExact identifier
spl id: b17d8b01-e4bf-4730-b154-c7c0d363e95a
spl set id: e040616b-bdca-4f5d-9d43-6dc64dc425f1

Reported adverse events (FAERS/openFDA)#

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