FDA.reportPublic FDA data

EXTRA STRENGTH PAIN RELIEF

Manufacturer
GERI-CARE PHARMACEUTICAL CORP
Effective date
2019-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:50:25

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 of age and older Take 1-2 Tablespoons every 4 to 6 hours as needed; not more than 8 Tablespoons in 24 hours Children under 12 years Do not use

Storage and handling

each tablespoon (15mL) contains: sodium 18mg TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at room temperature 15°-30°C (59°-86°F) protect from freezing and light for institutional use only

Label contents#

Full prescribing information#

Active ingredient (per tablespoonful = 15mL)

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:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablespoons 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

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 have

  • a sodium restricted diet
  • liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

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 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 1-2 Tablespoons every 4 to 6 hours as needed; not more than 8 Tablespoons in 24 hours
Children under 12 yearsDo not use

Other information

STORAGE AND HANDLING SECTION

  • each tablespoon (15mL) contains: sodium 18mg
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from freezing and light
  • for institutional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D & C yellow # 10, FD & C blue #1, flavor, glycerin, polyethylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

202202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-202-08ML - Milliliter57896-2022f554066-0509-4e5e-9e27-376aeeafb3a412018-06-11

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-20257896-202-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM CITRATE1Q73Q2JULRIACT

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
9a00a403-b525-fab1-e053-2995a90a68d96bdd435f-03e0-236d-e053-2991aa0a23062019-12-18WarningsExact identifier
spl id: 9a00a403-b525-fab1-e053-2995a90a68d9
spl set id: 6bdd435f-03e0-236d-e053-2991aa0a2306

Reported adverse events (FAERS/openFDA)#

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