EXTRAPRIN- acetaminophen, aspirin, caffeine tablet 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Extraprin

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID) **

Caffeine 65 mg

**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Uses

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

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 : 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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives 
  • facial swelling 
  • asthma (wheezing)
  • shock

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

  • more than 8 caplets 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • 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]
  • 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 other pain reliever/fever reducer
  • with any other product 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

  • 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 
  • any 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as 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 years: ask a doctor

Other information

  • store at 20°-25°C (68°-77°F) 
  • close cap tightly after use

Inactive ingredients

corn starch, hypromellose, microcrystalline cellulose, povidone, propylene glycol, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin. 

Questions?

call toll-free 1-800-935-6737

DRUG: Extraprin

GENERIC: ACETAMINOPHEN, ASPIRIN, CAFFEINE

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2734-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: PH052

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CAFFEINE 65mg in 1
  • ASPIRIN 250mg in 1
  • ACETAMINOPHEN 250mg in 1

INACTIVE INGREDIENT(S):

  • STARCH, CORN
  • HYPROMELLOSE, UNSPECIFIED
  • MICROCRYSTALLINE CELLULOSE
  • POVIDONE
  • PROPYLENE GLYCOL
  • SILICON DIOXIDE
  • STEARIC ACID
  • TITANIUM DIOXIDE
  • TRIACETIN

Remedy_Label

EXTRAPRIN 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2734(NDC:54257-858)
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
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code PH052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-2734-030 in 1 BLISTER PACK; Type 0: Not a Combination Product05/18/202010/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/18/202010/22/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2023
Document Id: 04b17367-4fa0-e425-e063-6294a90aa5ad
Set id: cd930467-6468-42b6-a66d-c3674fdb9439
Version: 5
Effective Time: 20230906
 
REMEDYREPACK INC.