Acetaminophen

Manufacturer
Delsam Pharma Llc
Effective date
2018-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:24

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

• this product does not contain directions or complete warnings for adult use • find right dose on chart. If possible, use weight to dose; otherwise, use age • mL = milliliter • if needed, repeat dose every 4 hours • do not use more than 5 doses in 24 hours • use enclosed dosing cup only. Do not use any other device Weight Age Dose under 24 lbs Under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 5mL 36 to 47 lbs ...

Storage and handling

• TAMPER EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing. • store at 20°- 25°C (68° - 77°F) • this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

Label contents#

Full prescribing information#

Active ingredient (in each 5mL)

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:

• the common cold • flu • headache • sore throat • toothache

Temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: 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: 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 • with any other product containing acetaminophen (prescription or nonprescription). 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 liver disease

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 (see overdose warning)

Stop use and ask a doctor if
• pain gets worse or last for more than 5 days
• fever gets worse or last for 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 the reach of children.
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children 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
• find right dose on chart. If possible, use weight to dose; otherwise, use age
• mL = milliliter
• if needed, repeat dose every 4 hours
• do not use more than 5 doses in 24 hours
• use enclosed dosing cup only. Do not use any other device

WeightAge Dose
under 24 lbsUnder 2 yearsask a doctor
24 to 35 lbs2 to 3 years5mL
36 to 47 lbs4 to 5 years7.5mL
48 to 59 lbs6 to 8 years10mL
60 to 71 lbs9 to 10 years12.5mL
72 to 95 lbs11 years15mL

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavour, Methylparaben, Propylparaben, Potassium sorbate, Citric Acid Monohydrate, Sorbitol, Propylene glycol, Sucralose, Povidone K30, Glycerin, FD&C Red #40, D&C Red #33 & Purified water.

Other information

STORAGE AND HANDLING SECTION

• TAMPER EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.

• store at 20°- 25°C (68° - 77°F)

• this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

SPL UNCLASSIFIED SECTION

Fast, Effective Relief of Children's Fever and Pain

  • Alcohol Free
  • Aspirin Free
  • Cherry Flavor

DOSAGE CUP ENCLOSED

​COMPARE TO the active ingredient of TYLENOL®*LIQUID

TAMPER EVIDENT

Child-Resistant Safety Cap Unbreakable Bottle

* Delsam Pharma Llc is not affiliated with the owner of the registered trademark Tylenol®

Distributed by

Delsam Pharma Llc

Bronx, Newyork 10467

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminop-1Acetaminop-1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72570-100-042023-03-16C16284748780-19d75b9d0-8ff8-f424-e053-dadaa90a57ceAcetaminophen LIQUID
72570-100-042020-01-31C16284748780-19d75b9d0-8ff8-f424-e053-dadaa90a57ceAcetaminophen LIQUID

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-10072570-100-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
5ed0b8ee-3f7e-4f0f-9c51-1e2a7a236d1f61766b7f-bd8d-4511-b12e-6470dca0d8492023-03-15WarningsExact identifier
spl set id: 61766b7f-bd8d-4511-b12e-6470dca0d849

Reported adverse events (FAERS/openFDA)#

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