ACETAMINOPHEN USP 80 MG FRUIT CHEW TABLET

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2015-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:28:08

Label at a glance#

ProductACETAMINOPHEN 80 MG FRUIT CHEW
Active ingredientACETAMINOPHEN
Label structure20 sections

Indications and uses

temporarily reduces fever and relieves minor aches and pains caused by headache the common cold flu toothache sore throat

Dosage and administration

this product does not contain directions or complete warnings for adult use do not take more than directed (see Overdose warning) find correct dose on chart below if possible, use weight to dose, otherwise use age chew tablets before swallowing give dose every 4 hours while symptoms last do not give more than 5 doses in 24 hours Weight (pounds) Age (years) Dose (tablets) 72-95 11-12 4-6 60-71 9-10 4-5 48-59 6-8 4 ...

Storage and handling

store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 80 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

temporarily reduces fever and relieves minor aches and pains caused by

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

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

OTHER SAFETY INFORMATION

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.

OTHER SAFETY INFORMATION

Sore throat warning: If sore throat is severe, lasts for more than 2 days or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly

OTC - DO NOT USE SECTION

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure wheater a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Drug Facts continued on back of label

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

These could be signs of a serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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 right away. Quick medical attention is critical for adults as well as for 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
  • do not take more than directed (see Overdose warning)
  • find correct dose on chart below
  • if possible, use weight to dose, otherwise use age
  • chew tablets before swallowing
  • give dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours
Weight (pounds)Age (years)Dose (tablets)
72-9511-124-6

60-71

9-104-5
48-596-84
36-474-53
24-352-32
under 24under 2ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Phenylketonurics: each tablet contains: phenylalanine 5 mg

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, compressible sugar, D&C red #27 (Al-lake), dextrose, FD&C yellow #6 (Al-lake), flavors, magnesium stearate, microcrystalline cellulose, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen 80 mg Fruit Chew TabletAcetaminophen 80 mg Fruit Chew TabletNDC 69618-012-03

FRUIT FLAVORED

Acetominophen USP 80 mg

PAIN RELIEVER

FEVER REDUCER

30 CHEWABLE TABLETS

*Compare to Active Ingredient in Children's TYLENOL®

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-012-032021-08-09C16284748780-19d75b9d0-b71c-f424-e053-dadaa90a57ceACETAMINOPHEN USP 80 MG FRUIT CHEW TABLET
69618-012-032020-01-31C16284748780-19d75b9d0-b71c-f424-e053-dadaa90a57ceACETAMINOPHEN USP 80 MG FRUIT CHEW TABLET

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-012-03EA - Each69618-012e1cdd41c-08b3-4c9e-952f-5a9f05b019ce12016-03-04

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
69618-01269618-012-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
c9279bd1-bbdc-1ca8-e053-2995a90aa7402707806f-8de4-4a2c-e054-00144ff8d46c2021-08-09WarningsExact identifier
spl set id: 2707806f-8de4-4a2c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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