FDA.reportPublic FDA data

ACETAMINOPHEN

Manufacturer
Akron Pharma Inc. | SLV Pharmaceuticals LLC
Effective date
2021-05-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:40:24

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-teaspoonful (tsp.) und...

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

NDC: 71399-0161-6SIZE 473 ML
NDC: 71399-0161-8SIZE 236 ML
NDC: 71399-0161- 4 SIZE 118 ML

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

• Compare To Active ingredient of Children's Tylenol Elixir

NDC 71399-0161-4

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

4 FL OZ (118 mL)

Akron Pharma

acetaminophen 118acetaminophen 118

• Compare To Active ingredient of Children's Tylenol Elixir

NDC 71399-0161-8

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

8 FL OZ (236 mL)

Akron Pharma

acetaminophen 236acetaminophen 236

• Compare To Active ingredient of Children's Tylenol Elixir

NDC 71399-0161-6

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

16 FL OZ (473 mL)

Akron Pharma

acetaminophen 473acetaminophen 473

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN4
307675acetaminophen 32 MG/ML Oral SolutionSCD4
307675acetaminophen 160 MG per 5 ML Oral SolutionSY4
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY4
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY4
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY4
307675APAP 32 MG/ML Oral SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-0161-42023-01-30C16284748780-1f386c64a-2a71-0266-e053-dadaa90a7c1aAcetaminophen Elixir Grape Flavor
71399-0161-62023-01-30C16284748780-1f386c64a-2a71-0266-e053-dadaa90a7c1aAcetaminophen Elixir Grape Flavor
71399-0161-82023-01-30C16284748780-1f386c64a-2a71-0266-e053-dadaa90a7c1aAcetaminophen Elixir Grape Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0161-4ACETAMINOPHEN118 mL in 1 BOTTLEELIXIR1184
71399-0161-6ACETAMINOPHEN473 mL in 1 BOTTLEELIXIR4734
71399-0161-8ACETAMINOPHEN236 mL in 1 BOTTLEELIXIR2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0161ACETAMINOPHEN ELIXIR [AKRON PHARMA INC.]4Legacy NDC, 3 package rows20210519_66f4db9a-7bc3-4a9e-a696-a4be2f71e675.zip

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
71399-016171399-0161-4, 71399-0161-8, 71399-0161-6

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
GRAPE6X543N684KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
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
c29e2c3a-9ec6-0b62-e053-2a95a90ac69c66f4db9a-7bc3-4a9e-a696-a4be2f71e6752021-05-18WarningsExact identifier
spl id: c29e2c3a-9ec6-0b62-e053-2a95a90ac69c
spl set id: 66f4db9a-7bc3-4a9e-a696-a4be2f71e675

Reported adverse events (FAERS/openFDA)#

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