Label: MEDPURINE tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 58599-016-30 - Packager: PURINEPHARMA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 27, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock
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
Ask a doctor before use if the stomach bleeding warning
you are taking a diuretic
you have a history of stomach problems, such as heartburn
You have high blood pressure, heart disease, liver cirrhosis, kidney disease
You have asthmaAsk a doctor or pharmacist before use if you are taking any other drugs containing an NSAID (prescription or nonprescription)
taking a blood thinning (anticoagulant) or steroid drug
taking a prescription drug for diabetes, gout or arthritis -
WHEN USING
Stop use and ask a doctor if an allergic reaction occurs. Seek medical 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, pain gets worse or lasts more than 10 days, redness or swelling is present, fever gets worse or lasts more than 3 days, any new symptoms occur, ringing in the ears or a loss of hearing occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions drink a full glass of water with each dose. Swallow whole. Do not chew or crush. Do not exceed recommended dose.
Adults and children 12 years and older: Take 4-8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours unless directed by a doctor.
Children under 12: Ask a doctor. - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MEDPURINE
medpurine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58599-016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID (UNII: 1CS02G8656) GLATIRAMER ACETATE (UNII: 5M691HL4BO) CLOSPIRAZINE HYDROCHLORIDE (UNII: N6B142V0U0) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TALC (UNII: 7SEV7J4R1U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (Yellow) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code O Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58599-016-30 120 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 04/14/2015 Labeler - PURINEPHARMA LLC (019950491) Registrant - PURINEPHARMA LLC (019950491) Establishment Name Address ID/FEI Business Operations PURINEPHARMA LLC 019950491 RELABEL(58599-016) Establishment Name Address ID/FEI Business Operations Time-Cap Lab lnc 037052099 MANUFACTURE(58599-016)
