FDA.reportPublic FDA data

Extra Strength Pain Relief

Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2021-05-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:45:23

Label at a glance#

ProductExtra Strength Pain Relief
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

• temporarily relieves minor aches and pains • temporarily reduces fever

Dosage and administration

• do not take more than directed • adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours • children under 12 years: do not use

Storage and handling

• TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. • store at 20⁰C-25⁰C (68⁰F-77⁰F) • for institutional use only   Bottle of 20 NDC 68788-7709-02 Bottle of 30 NDC 68788-7709-03 Bottle of 45 NDC 68788-7709-04 Bottle of 50 NDC 68788-7709-05 Bottle of 60 NDC 68788-7709-06 Bottle of 100 NDC 68788-7709-01

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 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 you take

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

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

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
  • children under 12 years: do not use

Other Information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • for institutional use only
  • Bottle of 20 NDC 68788-7709-02
    Bottle of 30 NDC 68788-7709-03
    Bottle of 45 NDC 68788-7709-04
    Bottle of 50 NDC 68788-7709-05
    Bottle of 60 NDC 68788-7709-06
    Bottle of 100 NDC 68788-7709-01

Inactive Ingredients

INACTIVE INGREDIENT SECTION

povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gericare

NDC 68788-7709

Non-Aspirin

Extra Strength

PAIN RELIEF

Acetaminophen Tablets

Pain Reliever / Fever Reducer

Compare to active ingredient in Extra Strength Tylenol Tablets*

PACKAGE NOT CHILD RESISTANT

500 mg each

Extra Strength APAP Tab 500mg
Extra Strength APAP Tab 500mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7709-1EA - Each68788-7709612eb14a-e274-4116-9656-134de5dbe36d12020-08-06
68788-7709-2EA - Each68788-7709f6be4213-03c1-42b9-a775-8f1d7d710aa212020-08-06
68788-7709-3EA - Each68788-77094aeb4d6a-55db-483f-a43a-2b05b282fbf312020-08-06
68788-7709-4EA - Each68788-7709ff16ff2f-7cd4-4a19-9905-9373f1262cb612020-08-06
68788-7709-5EA - Each68788-7709a3298b41-d70a-450c-8467-6fdf412034bf12020-08-06
68788-7709-6EA - Each68788-770903ea209a-cd4a-44c6-908f-bd8d86562da212020-08-06
57896-201-01EA - Each57896-20182dbdfae-7cce-45e7-bf0c-c214686bb89612012-07-24
57896-201-05EA - Each57896-2015d0770cd-70c2-4757-896d-62e868f751c012022-06-06
57896-201-10EA - Each57896-201aa5f4c60-e670-45f2-861b-c2ad8e686e2a12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-770968788-7709-2, 68788-7709-3, 68788-7709-4, 68788-7709-5, 68788-7709-6, 68788-7709-1
57896-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp7570aaa2-3238-4cd3-b788-915caa970dba2025-12-04WarningsExact identifier
ndc (product): 57896-201
1c7b5d4b-b5b4-4690-8adb-5672dffa7197f165a9f5-1253-43c3-9e41-bf33e244f5752022-09-06WarningsExact identifier
spl set id: f165a9f5-1253-43c3-9e41-bf33e244f575

Reported adverse events (FAERS/openFDA)#

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