Prescription Drug Information: Ketorolac Tromethamine (Page 7 of 7)

HOW SUPPLIED

Ketorolac tromethamine tablets, USP are available as follows:

10 mg: White, round, convex, unscored, film-coated tablets, debossed “93” on one side and “314” on the other side. They are available in

NDC: 70518-0048-00

NDC: 70518-0048-01

NDC: 70518-0048-02

NDC: 70518-0048-03

NDC: 70518-0048-04

PACKAGING: 25 in 1 BOTTLE PLASTIC

PACKAGING: 1 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOTTLE

PACKAGING: 8 in 1 BOTTLE PLASTIC

PACKAGING: 20 in 1 BOTTLE PLASTIC

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

PROTECT FROM LIGHT AND EXCESSIVE HUMIDITY.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
  • with increasing doses of NSAIDs
  • with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
  • anytime during use
  • without warning symptoms
  • that may cause death

The risk of getting an ulcer or bleeding increases with:

  • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
  • increasing doses of NSAIDs
  • older age
  • longer use of NSAIDs
  • poor health
  • smoking
  • advanced liver disease
  • drinking alcohol
  • bleeding problems

NSAIDs should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take NSAIDs?

Do not take NSAIDs:

  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems
  • have high blood pressure
  • have asthma
  • are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
  • are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

  • shortness of breath or trouble breathing
  • slurred speech
  • chest pain
  • swelling of the face or throat
  • weakness in one part or side of your body

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • vomit blood
  • more tired or weaker than usual
  • there is blood in your bowel movement or it
  • diarrhea

is black and sticky like tar

  • itching
  • unusual weight gain
  • your skin or eyes look yellow
  • skin rash or blisters with fever
  • indigestion or stomach pain
  • swelling of the arms, legs, hands and feet
  • flu-like symptoms

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

  • Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Ketorolac Tromethamine

GENERIC: Ketorolac Tromethamine

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0048-0

NDC: 70518-0048-1

NDC: 70518-0048-2

NDC: 70518-0048-3

NDC: 70518-0048-4

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: 93;314

PACKAGING: 25 in 1 BOTTLE, PLASTIC

PACKAGING: 1 in 1 BOTTLE, PLASTIC

PACKAGING: 100 in 1 BOTTLE

PACKAGING: 8 in 1 BOTTLE, PLASTIC

PACKAGING: 20 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • KETOROLAC TROMETHAMINE 10mg in 1

INACTIVE INGREDIENT(S):

  • HYDROXYPROPYL CELLULOSE (90000 WAMW)
  • HYPROMELLOSE 2910 (3 MPA.S)
  • HYPROMELLOSE 2910 (50 MPA.S)
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • POLYETHYLENE GLYCOL 400
  • TITANIUM DIOXIDE
Remedy_Label
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MM2
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MM3
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MM4
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MM5
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KETOROLAC TROMETHAMINE
ketorolac tromethamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0048(NDC:0093-0314)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 93;314
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0048-0 25 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70518-0048-1 1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:70518-0048-2 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70518-0048-3 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:70518-0048-4 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074754 12/09/2016
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2022 REMEDYREPACK INC.

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