EXTRA STRENGTH PAIN RELIEVER

Manufacturer
PHARMACY VALUE ALLIANCE, LLC | Geri-Care Pharmaceutical Corp
Effective date
2024-11-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:48:30

Label at a glance#

ProductEXTRA STRENGTH PAIN RELIEVER
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains due to a cold toothache headache muscular aches arthritis premenstrual and menstrual cramps

Dosage and administration

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

ACETAMINOPHEN 250 MG

ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug)

CAFFEINE 65 MG

Purposes

OTC - PURPOSE SECTION

PAIN RELIEVER - PAIN RELIEVER AID

USES

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to
  • a cold
  • toothache
  • headache
  • muscular aches
  • arthritis
  • premenstrual and menstrual cramps

WARNINGS

WARNINGS SECTION

See carton for complete warnings

Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or
flu-like symptoms should not use this product. When using this product, if changes in
behavior with nausea and vomiting occur, consult a doctor because these symptoms could
be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
• hives • facial swelling • asthma (wheezing) • shock
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • rash
• skin reddening • blisters If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing
acetaminophen • 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach
bleeding. The chance is higher if you • have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription
or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • are age 60 or older
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
Caffeine warning: The recommended dose of this product contains about as much
caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or
beverages while taking this product because too much caffeine may cause nervousness,
irritability, sleeplessness, and, occasionally, rapid heartbeat.

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • 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 you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional
before use. It is especially important not to use aspirin during
the last 3 months of pregnancy unless definitely directed to do
so by a doctor because it may cause problems in the unborn
child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact
a Poison Control Center (1-800-222-1222) right away. Prompt 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 use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  • children under 12: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, hypromellose,
microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate,
sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-762-002022-11-30C16284748780-1d6a99b39-810f-a426-e053-dadaa90af4c2PV 226L (216)
68016-762-002022-01-28C16284748780-1d6a99b39-810f-a426-e053-dadaa90af4c2PV 226L (216)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-762EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [PHARMACY VALUE ALLIANCE, LLC]4Legacy NDC20241130_b686549f-4daf-f4c0-e053-2a95a90afb56.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-76268016-762-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
27fe2888-f71d-d953-e063-6394a90af580b686549f-4daf-f4c0-e053-2a95a90afb562024-11-28WarningsExact identifier
spl id: 27fe2888-f71d-d953-e063-6394a90af580
spl set id: b686549f-4daf-f4c0-e053-2a95a90afb56

Reported adverse events (FAERS/openFDA)#

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