EXAPRIN- acetaminophen, aspirin, caffeine, salicylamide tablet

EXAPRIN by

Drug Labeling and Warnings

EXAPRIN by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet):

Acetaminophen 110mg

Aspirin (NSAID*) 162mg (*nonsteroidal anti-inflammatory drug)

Caffeine 32.4mg

Salicylamide (NSAID)* 152mg (*nonsteroidal anti-inflammatory drug)

PURPOSE

Purpose:

Pain Reliever / Fever Reducer

Pain Reliever / Fever Reducer

Pain Reliever Aid

Pain Reliever / Fever Reducer

INDICATIONS & USAGE

Uses:

Temporarily relieves minor aches and pains due to

• headache
• backache
• muscular aches
• minor arthritis pain
• the common cold
• toothache
• menstrual cramps

Temporarily reduces fever

WARNINGS

Warnings:

Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Acetaminophen and aspirin may cause severe allergic reactions which may include hives, skin reddening, blisters, rash, facial swelling, asthma (wheezing), or shock

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 products containing acetaminophen
• 3 more 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 more or for a longer time than directed
• take a blood thinning (anticoagulant) or steroid drug
• have 3 or more alcohol drinks every day while using this product
• take other drugs containing prescription or non-prescription NSAIDS (aspirin, ibuprofen, naproxen, others)

DO NOT USE

Do not use

• with any other drug containing acetaminophen (prescription or non-prescription)
• if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

ASK DOCTOR

Ask a doctor before use if

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you

• take any other drug containing an NSAID
• take a blood thinning (anticoagulant) or steroid drug
• take any drug for diabetes, gout, or arthritis
• do not know if other drugs you are taking contain acetaminophen

STOP USE

Stop use and ask a doctor if

• an allergic reaction occurs, seek medical help right away
• new symptoms occur
• fever worsens or lasts more than 3 days
• pain worsens or lasts more than 10 days
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs
• you have any of the following signs of stomach bleeding: feel faint, vomit blood, or have bloody or black stools, or stomach pain that does not get better

These could be signs of a serious condition

PREGNANCY OR BREAST FEEDING

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 is may cause problems in the unborn child or complications during delivery

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

OVERDOSAGE

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions:

do not take more than directed.

Adults and children 12 years of age and over:

• take 1 or 2 tablets with water every 4 hours while sympotms persist
• do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Starch, Stearic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXAPRIN 
acetaminophen, aspirin, caffeine, salicylamide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	110 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	162 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.4 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC)	SALICYLAMIDE	152 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	EXA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0105-3	20 in 1 BOX, UNIT-DOSE	01/20/1987
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0105-4	50 in 1 BOX, UNIT-DOSE	01/20/1987
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50332-0105-7	125 in 1 BOX, UNIT-DOSE	01/20/1987
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 50332-0105-8	250 in 1 BOX, UNIT-DOSE	01/20/1987
4		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/20/1987

Labeler - HART Health (069560969)