FDA.reportPublic FDA data

Extraprin

Manufacturer
REMEDYREPACK INC.
Effective date
2021-10-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:34:18

Label at a glance#

ProductExtraprin
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & 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 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID) **

Caffeine 65 mg

**nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2734-02023-10-16C16284748780-1f386c64a-187c-0266-e053-dadaa90a7c1aExtraprin
70518-2734-02023-01-30C16284748780-1f386c64a-187c-0266-e053-dadaa90a7c1aExtraprin

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-273470518-2734-0
54257-858

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
ndc (product): 54257-858
04b17367-4fa0-e425-e063-6294a90aa5adcd930467-6468-42b6-a66d-c3674fdb94392023-09-06WarningsExact identifier
spl set id: cd930467-6468-42b6-a66d-c3674fdb9439

Reported adverse events (FAERS/openFDA)#

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