DiMentho (Page 5 of 5)

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

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

Issued 01/2017

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

- longer use of NSAIDs

- smoking

- drinking alcohol

- older age

- poor health

- advanced liver disease

- 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. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 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:

- new or worse high blood pressure

- liver problems including liver failure

- low red blood cells (anemia)

- life-threatening allergic reactions

- heart failure

- kidney problems including kidney failure

- life-threatening skin 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

- chest pain

- weakness in one part or side of your body

- slurred speech

- swelling of the face or throat

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

- nausea

- more tired or weaker than usual

- diarrhea

- itching

- your skin or eyes look yellow

- indigestion or stomach pain

- flu-like symptoms

- vomit blood

- there is blood in your bowel movement, or it is black and sticky like tar

- unusual weight gain

- skin rash or blisters with fever

- swelling of the arms, legs, hands and feet

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.

Mfd. for: IPG Pharmaceuticals, Inc. Tempe, AZ 85281
Made in Canada

Issued: January 2017    PPK-8367-0    55

For more information, call 1-866-923-4914.

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DIMENTHO
diclofenac sodium 1.5% solution, menthol 10% topical liquid, and kinesiology tape kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71905-300
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71905-300-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 150 mL
Part 2 1 BOTTLE 89 mL
Part 1 of 2
DICLOFENAC SODIUM
diclofenac sodium solution
Product Information
Item Code (Source) NDC:71085-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYL SULFOXIDE
ALCOHOL
GLYCERIN
PROPYLENE GLYCOL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 150 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203818 11/26/2014
Part 2 of 2
BIOTEMPER
menthol liquid
Product Information
Item Code (Source) NDC:71718-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
ARNICA MONTANA
FRANKINCENSE
CAMPHOR (SYNTHETIC)
FRANKINCENSE OIL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
LAVENDER OIL
PROPYLENE GLYCOL
TEA TREE OIL
THYMOL
.ALPHA.-TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 89 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203818 10/01/2019
Labeler — Levins Pharmaceuticals, LLC (080839485)

Revised: 10/2019 Levins Pharmaceuticals, LLC

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