Label: EXAPRIN- acetaminophen, aspirin, caffeine, salicylamide tablet
- NDC Code(s): 50332-0105-3, 50332-0105-4, 50332-0105-7, 50332-0105-8
- Packager: HART Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 12, 2012
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- 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)
Close - PURPOSE
Purpose:
Pain Reliever / Fever Reducer
Pain Reliever / Fever Reducer
Pain Reliever Aid
Pain Reliever / Fever Reducer
Close - 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
Close - 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: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), or shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours, which is the maximum daily amount
- 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 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 yo9u
- 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 in the painful area
- ringing in the ears or loss of hearing occurs
- you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
These could be signs of a serious condition
Close - 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
Close - 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 cas eof overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
Close - 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: do not use; this will provide more than the recommended dose (overdose) and my cause liver damage
Close - INACTIVE INGREDIENT
Inactive Ingredients: Corn Starch, FD&C Yellow #6 Lake, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Stearic Acid
Close - INGREDIENTS AND APPEARANCE
EXAPRIN
acetaminophen, aspirin, caffeine, salicylamide tabletProduct 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 1 2 in 1 PACKET 2 NDC:50332-0105-4 50 in 1 BOX, UNIT-DOSE 2 2 in 1 PACKET 3 NDC:50332-0105-7 125 in 1 BOX, UNIT-DOSE 3 2 in 1 PACKET 4 NDC:50332-0105-8 250 in 1 BOX, UNIT-DOSE 4 2 in 1 PACKET 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)