MEDPURINE by PURINEPHARMA LLC / Time-Cap Lab lnc MEDPURINE tablet

MEDPURINE by

Drug Labeling and Warnings

MEDPURINE by is a Otc medication manufactured, distributed, or labeled by PURINEPHARMA LLC, Time-Cap Lab lnc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet): Aspirin 81 mg (NSAID)1

1 nonsteroidal anti-inflammatory drug

PURPOSE

Purpose: Pain reliever

INDICATIONS & USAGE

Uses For the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. Ask your doctor about other uses of aspirin.

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

Do not use if you are allergic to aspirin or any other pain reliever / fever reducer.

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 asthma

Ask 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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Other information save carton for full directions and warnings. Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients: Microcrystalline Cellulose, Modified Starch, Pregelatinized Starch, Colloidal Silicon Dioxide, Stearic Acid, Hypromellose, Methacrylic Acid Copolymer Dispersion, Triethyl Citrate, Polysorbate 80, Talc, FD&C Yellow #10, FD&C Yellow #6, Titanium Dioxide.

HOW SUPPLIED

NDC: 58599-016-30: 120 Count in a Bottle

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDPURINE 
medpurine tablet

Product 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)