FDA.reportPublic FDA data

Perrigo Pain Relief Tablets Drug Facts

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:35

Label at a glance#

Productgood sense pain relief
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

1. temporarily relieves minor aches and pains due to: 2. the common cold 3. headache 4. minor pain of arthritis 5. backache 6. muscular aches 7. toothache 8. premenstrual and menstrual cramps 9. temporarily reduces fever

Dosage and administration

• do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 tablets every 4 to 6 hours while symptoms last • do not take more than 10 tablets in 24 hours • do not use for more than 10 days unless directed by a doctor children 6-11 years • take 1 tablet every 4 to 6 hours while symptoms last • do not take more than 5 tablets in 24 hours • do not use for more than 5 days un...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  1. temporarily relieves minor aches and pains due to:
  2. the common cold
  3. headache
  4. minor pain of arthritis
  5. backache
  6. muscular aches
  7. toothache
  8. premenstrual and menstrual cramps
  9. temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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 the user has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user

OTC - ASK DOCTOR SECTION

  1. has liver disease
  2. is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  1. new symptoms occur
  2. pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  3. fever gets worse or lasts more than 3 days
  4. redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

  • do not take more than directed (see overdose warning)

adults and children 12 years and over

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children

6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a
  • doctor

children under

6 years

ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE®

Regular Strength

Pain Relief TABLETS

Pain Reliever/Fever Reducer

Acetaminophen

Tablets - 325 mg Each

Repackaged By: Preferred Pharmaceuticals Inc.

Compare to active ingredient of Regular Strength Tylenol®

Acetaminophen Tablets 325mg
Acetaminophen Tablets 325mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN1
313782acetaminophen 325 MG Oral TabletSCD1
313782APAP 325 MG Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8821-1good sense pain relief100 in 1 BOTTLETABLET1001
68788-8821-3good sense pain relief30 in 1 BOTTLETABLET301
68788-8821-6good sense pain relief60 in 1 BOTTLETABLET601
68788-8821-9good sense pain relief90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8821GOOD SENSE PAIN RELIEF (ACETAMINOPHEN) TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250125_523b68da-cd2a-4960-95e7-de5d51ce33c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8821-1EA - Each68788-882155cbc8f7-52b3-4f02-81cf-db04e9361a5812025-03-04
68788-8821-3EA - Each68788-8821b467607d-096b-456a-bbd7-46fb707dbdaa12025-03-04
68788-8821-6EA - Each68788-88210fb9c80e-4d56-43d4-9ffc-c11a78e0e52012025-03-04
68788-8821-9EA - Each68788-882186d610f0-958c-491c-8d74-87b77db7964712025-03-04
0113-0403-78EA - Each0113-04036e8d8f22-2a1f-4f1b-bfb4-b913ba35bc9c12019-09-05

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-882168788-8821-3, 68788-8821-6, 68788-8821-9, 68788-8821-1
0113-0403

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense pain reliefACETAMINOPHENPreferred Pharmaceuticals Inc.523b68da-cd2a-4960-95e7-de5d51ce33c12025-01-23WarningsExact identifier
ndc (package): 68788-8821-3
ndc (package): 68788-8821-6
ndc (package): 68788-8821-1
ndc (package): 68788-8821-9
ndc (product): 68788-8821
ndc11 (package): 68788882109
ndc11 (package): 68788882101
ndc11 (package): 68788882103
ndc11 (package): 68788882106
spl id: 523b68da-cd2a-4960-95e7-de5d51ce33c1
spl set id: 523b68da-cd2a-4960-95e7-de5d51ce33c1
good sense pain reliefACETAMINOPHENL. Perrigo Company8b56bfc0-2253-458d-99a6-0b0f9ae0ba502024-10-21WarningsExact identifier
ndc (product): 0113-0403

Reported adverse events (FAERS/openFDA)#

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