FDA.reportPublic FDA data

ACETAMINOPHEN

Manufacturer
ATLANTIC BIOLOGICALS CORP | UNIT DOSE SOLUTIONS
Effective date
2023-03-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:27

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use shake well before using mL=milliliter find the right dose on chart below, if possible, use weight to dose; otherwise use age use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.  if needed, repeat dose every 4 hours while symptoms last  do not give more than 5 times in 24 hours  do not gi...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

trmporarily:

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount 
  • with other drugs containing acetaminophen.

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:

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

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 - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning:

OVERDOSAGE SECTION

In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical
attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • shake well before using
  • mL=milliliter
  • find the right dose on chart below, if possible, use weight to dose; otherwise use age
  • use only the enclosed dosing cup designed for use with this product.
  • Do not use any other dosing device. 
  • if needed, repeat dose every 4 hours while symptoms last 
  • do not give more than 5 times in 24 hours 
  • do not give more than 5 days unless directed by doctor.
Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.)
 under 24 under 2 ask a doctor
 24 to 35 2 to 3 1 tsp or 5 mL
 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL
 48 to 59 6 to 8 2 tsp or 10 mL
 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL
 72 to 95 11 3 tsp or 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, glycerin, polyethylene glycol 400, purified water, sodium citrate, saccharin sodium, sorbitol solution & sodium benzoate.

Questions or Comments?

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

DISTRIBUITED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN2
307675acetaminophen 32 MG/ML Oral SolutionSCD2
307675acetaminophen 160 MG per 5 ML Oral SolutionSY2
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY2
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY2
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY2
307675APAP 32 MG/ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
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c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0166-12025-01-30C16284748780-12cef2736-877c-d83d-e063-dadaa90ab31fAcetaminophen Elxir Bubble Gum Flavor
17856-0166-32025-01-30C16284748780-12cef2736-877c-d83d-e063-dadaa90ab31fAcetaminophen Elxir Bubble Gum Flavor
17856-0166-52025-01-30C16284748780-12cef2736-877c-d83d-e063-dadaa90ab31fAcetaminophen Elxir Bubble Gum Flavor
17856-0166-72025-01-30C16284748780-12cef2736-877c-d83d-e063-dadaa90ab31fAcetaminophen Elxir Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0166-1ACETAMINOPHEN72 in 1 BOX, UNIT-DOSEELIXIR722
17856-0166-2ACETAMINOPHEN10.15 mL in 1 CUP, UNIT-DOSEELIXIR10.152
17856-0166-3ACETAMINOPHEN50 in 1 BOX, UNIT-DOSEELIXIR502
17856-0166-4ACETAMINOPHEN20.31 mL in 1 CUP, UNIT-DOSEELIXIR20.312
17856-0166-5ACETAMINOPHEN72 in 1 BOX, UNIT-DOSEELIXIR722
17856-0166-6ACETAMINOPHEN15 mL in 1 CUP, UNIT-DOSEELIXIR152
17856-0166-7ACETAMINOPHEN50 in 1 BOX, UNIT-DOSEELIXIR502
17856-0166-8ACETAMINOPHEN31.2 mL in 1 CUP, UNIT-DOSEELIXIR31.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0166ACETAMINOPHEN ELIXIR [ATLANTIC BIOLOGICALS CORP]2Legacy NDC, 8 package rows20230314_57b9b32c-6a5c-49d7-b4df-e0489a98168c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0166-1ML - Milliliter17856-01669225ee42-5e40-417c-8084-dfcad7bff92412023-06-06
17856-0166-3ML - Milliliter17856-0166be1d41bb-feef-4f75-ae3e-15c3a339c1eb12023-06-06
17856-0166-5ML - Milliliter17856-0166067cab20-451e-4e77-a8da-8838f258b66b12023-06-06
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
17856-016617856-0166-2, 17856-0166-1, 17856-0166-4, 17856-0166-3, 17856-0166-8, 17856-0166-7, 17856-0166-6, 17856-0166-5
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
bbed8399-0702-43e3-a991-6ff6024a1cdd57b9b32c-6a5c-49d7-b4df-e0489a98168c2023-03-13WarningsExact identifier
spl id: bbed8399-0702-43e3-a991-6ff6024a1cdd
spl set id: 57b9b32c-6a5c-49d7-b4df-e0489a98168c

Reported adverse events (FAERS/openFDA)#

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