EXTRA STRENGTH PAIN RELIEVER by PHARMACY VALUE ALLIANCE, LLC / Geri-Care Pharmaceutical Corp PV 226L (216)

EXTRA STRENGTH PAIN RELIEVER by

Drug Labeling and Warnings

EXTRA STRENGTH PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE, LLC, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin and caffeine tablet, film coated 
PHARMACY VALUE ALLIANCE, LLC

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PV 226L (216)

Active ingredients (in each caplet)

ACETAMINOPHEN 250 MG

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

CAFFEINE 65 MG

Purposes

PAIN RELIEVER - PAIN RELIEVER AID

USES

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

WARNINGS

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.

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.

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

  • 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

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

INACTIVE INGREDIENTS

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

Questions or comments?

1-800-540-3765

Package label

1

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68016-762
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size17mm
FlavorImprint Code 44;334
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68016-762-001 in 1 CARTON01/01/2020
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/01/202001/31/2026
Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2024