EXTRAPRIN- acetaminophen, aspirin, caffeine tablet

Extraprin by

Drug Labeling and Warnings

Extraprin by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

HOW SUPPLIED

Extraprin Extra Strength 250mg/250mg/65mg Tablets, capsule shaped white, imprint PH052

NDC: 70518-2734-00 30 in 1 BLISTER PACK

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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

INGREDIENTS AND APPEARANCE

EXTRAPRIN 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-2734(NDC:54257-858)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	PH052
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-2734-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/18/2020

Labeler - REMEDYREPACK INC. (829572556)