Childrens Chewable Acetaminophen

Manufacturer
BLESSINGS INTERNATIONAL | Geri-Care Pharmaceutical Corp
Effective date
2023-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:59

Label at a glance#

ProductChildrens Chewable Acetaminophen
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains temporarily reduces fever

Dosage and administration

Chew tablets thoroughly before swallowing. This product does not contain directions or complete warnings for adults. Follow dosage on table or use as doctor directs. If possible use weight to dose; otherwise use age. Give every 4 hours as needed; do not give more than 5 doses in 24 hours. Administer only under adult supervision. DO NOT EXCEED DOSE SHOWN. See Overdose Warning. Weight (lbs) Under 24 24-35 36-47 48-5...

Storage and handling

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at 20°C-25°C (68°F-77°F); avoid high humidity Keep tightly closed Phenylketonurics: contains phenylalanine 5mg per tablet.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 80 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains
  • 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.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug 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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: 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

Chew tablets thoroughly before swallowing.
This product does not contain directions or complete warnings for adults.
Follow dosage on table or use as doctor directs. If possible
use weight to dose; otherwise use age. Give every 4 hours
as needed; do not give more than 5 doses in 24 hours.
Administer only under adult supervision.
DO NOT EXCEED DOSE SHOWN. See Overdose Warning.

Weight (lbs)Under 2424-3536-4748-5960-7172-95
AgeUnder 22-34-56-89-1011
TabletsAsk Doctor23456

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20°C-25°C (68°F-77°F); avoid high humidity
  • Keep tightly closed
  • Phenylketonurics: contains phenylalanine 5mg per tablet.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aspartame (contains phenylalanine), cellulose, D&C Red #27, Dextrose, FD&C Yellow #6, fruit flavor,
magnesium stearate, Prosweet, stearic acid, sugar.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307696acetaminophen 80 MG Chewable TabletPSN2
307696acetaminophen 80 MG Chewable TabletSCD2
307696APAP 80 MG Chewable TabletSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51376-130-10Childrens Chewable Acetaminophen1000 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51376-130CHILDRENS CHEWABLE ACETAMINOPHEN (ACETAMINOPHEN) TABLET, CHEWABLE [BLESSINGS INTERNATIONAL]2Current NDC, Legacy NDC, 1 package rows20231019_ee8ba190-2c42-7ca2-e053-2a95a90a01a0.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
51376-13051376-130-10

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
Childrens Chewable AcetaminophenACETAMINOPHENBLESSINGS INTERNATIONALee8ba190-2c42-7ca2-e053-2a95a90a01a02023-10-17WarningsExact identifier
ndc (package): 51376-130-10
ndc (product): 51376-130
ndc11 (package): 51376013010
spl id: 07eed601-b5e7-f430-e063-6294a90ab1b3
spl set id: ee8ba190-2c42-7ca2-e053-2a95a90a01a0

Reported adverse events (FAERS/openFDA)#

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