NDC | 50332-0105-3, 50332-0105-4, 50332-0105-7, 50332-0105-8 |
Set ID | 9fe82229-cc3e-4d79-a448-014fe3d0055b |
Category | HUMAN OTC DRUG LABEL |
Packager | HART Health |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
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
- 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
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 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)