Acetaminophen

Manufacturer
WALGREEN CO. | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:03:40

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) chew or crush tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablet...

Storage and handling

store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light. do not use if carton is open or if printed seal on blister is broken or missing.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)


Acetaminophen USP 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
    • soar 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

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. (1-800-222-1222)
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 give more than directed (see overdose warning)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)
Age (yr)
Dose (tablets)*
under 24
under 2 years
ask a doctor
24 to 35 lbs
2 to 3 years
1 tablet
36 to 47 lbs
4 to 5 years
1½ tablets
48 to 59 lbs
6 to 8 years
2 tablets
60 to 71 lbs
9 to 10 years
2½ tablets
72 to 95 lbs
11 years
3 tablets

* or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
  • do not use if carton is open or if printed seal on blister is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-274-4122

  DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2021 Walgreen Co.
MADE IN INDIA

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (24 Chewable Tablets Bottle Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-9605-07

Walgreens
Compare to the active ingredient
in Children's Tylenol ®Chewables ††

Children's
Pain & Fever
ACETAMINOPHEN 160 mg
PAIN RELIEVER / FEVER REDUCER

Chewables
Chew or crush tablets completely before swallowing
Aspirin Free              Ibuprofen Free

AGES
2-11
YEARS

24CHEWABLE TABLETS            ACTUAL SIZE                Bubble Gum flavor
160 mg each

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (24 Chewable Tablets Bottle Carton Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (24 Chewable Tablets Bottle Carton Label)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313820acetaminophen 160 MG Chewable TabletPSN6
313820acetaminophen 160 MG Chewable TabletSCD6
313820APAP 160 MG Chewable TabletSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9605-07Acetaminophen6 in 1 BLISTER PACKTABLET66
0363-9605-07Acetaminophen4 in 1 CARTONTABLET46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9605ACETAMINOPHEN TABLET [WALGREEN CO.]6Current NDC, Legacy NDC, 2 package rows20231208_c20c814b-35f5-4c46-e053-2a95a90a50f2.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-96050363-9605-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
AcetaminophenACETAMINOPHENWALGREEN CO.c20c814b-35f5-4c46-e053-2a95a90a50f22023-12-08WarningsExact identifier
ndc (package): 0363-9605-07
ndc (product): 0363-9605
ndc11 (package): 00363960507
spl id: 0bfa94dc-1f27-efa5-e063-6394a90aa629
spl set id: c20c814b-35f5-4c46-e053-2a95a90a50f2

Reported adverse events (FAERS/openFDA)#

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