FDA.reportPublic FDA data

EXTRA STRENGTH PAIN RELIEF

Manufacturer
GERI-CARE PHARMACEUTICAL CORP
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:30:26

Label at a glance#

ProductEXTRA STRENGTH PAIN RELIEF
Active ingredientACETAMINOPHEN
Label structure10 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 of age and older Take 1 to 2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours. Do not take for more than 10 days unless directed by a doctor Children under 12 years ask a doctor

Storage and handling

store at room temperature 15°- 30°C (59°-86°F) protect from freezing protect from light TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.

Label contents#

Full prescribing information#

Active ingredient (in each 15mL Tablespoonful)

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. The maximum
daily dose of this product is 6 tablespoonfuls in 24 hours.
Severe liver damage may occur if you take
• more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24
hours • with other drugs containing acetaminophen
• 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you haveliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breastfeeding,ask a health professional before use.

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
Adults and children 12 years of age and olderTake 1 to 2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours. Do not take for more than 10 days unless directed by a doctor
Children under 12 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°- 30°C (59°-86°F)
  • protect from freezing
  • protect from light
  • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

RECENT MAJOR CHANGES SECTION

correct typographical errors in dosage section

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GeriAPAP206GeriAPAP206

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357896202088GTIN-13: 0357896202088
EAN-13: 0357896202088
GTIN-12: 357896202088
UPC-A: 357896202088
GTIN storage (14 digits): 00357896202088		GeriAPAP206.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-206-082021-03-15C16284748780-1ab0e2407-31c0-f274-e053-dbdaa90a6471GerCare- APAP SUS Extra 206
57896-206-082020-09-27C16284748780-1ab0e2407-31c0-f274-e053-dbdaa90a6471GerCare- APAP SUS Extra 206
57896-206-082020-09-25C16284748780-1ab0e2407-31c0-f274-e053-dbdaa90a6471GerCare- APAP SUS Extra 206
57896-206-082020-07-22C16284748780-1ab0e2407-31c0-f274-e053-dbdaa90a6471GerCare- APAP SUS Extra 206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-206-08EXTRA STRENGTH PAIN RELIEF237 mL in 1 BOTTLESUSPENSION2377

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-206-08ML - Milliliter57896-206d1a06ed3-3d58-4a6f-a4cc-d7b2a3a5117f12020-01-03

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-20657896-206-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP99ec63ef-aa28-c2fb-e053-2a95a90a9f6d2025-12-31WarningsExact identifier
ndc (package): 57896-206-08
ndc (product): 57896-206
ndc11 (package): 57896020608
spl id: 4742eecd-767f-3e30-e063-6394a90a86ed
spl set id: 99ec63ef-aa28-c2fb-e053-2a95a90a9f6d

Reported adverse events (FAERS/openFDA)#

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