SALLUS Pain Relief Collection with Naproxen (Page 5 of 6)

HOW SUPPLIED

Naproxen Tablets USP:
250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one side and ‘250’ on the other side. Packaged in light-resistant bottles of 100 and 500.
100’s (bottle): NDC 68462-188-01
500’s (bottle): NDC 68462-188-05
375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. Packaged in light-resistant bottles of 60, 100 and 500.
60’s (bottle): NDC 68462-189-60
100’s (bottle): NDC 68462-189-01
500’s (bottle): NDC 68462-189-05
500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. Packaged in light-resistant bottles of 30, 50, 60, 100 and 500.
30’s (bottle): NDC 68462-190-30
50’s (bottle): NDC 68462-190-50
60’s (bottle): NDC 68462-190-60
100’s (bottle): NDC 68462-190-01
500’s (bottle): NDC 68462-190-05
Store at 15° to 30°C (59° to 86°F) in well-closed containers; dispense in light-resistant containers.

Naproxen Sodium Tablets USP:
275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. Packaged in bottles of 100 and 500
100’s (bottle): NDC 68462-178-01
500’s (bottle): NDC 68462-178-05
550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. Packaged in bottles of 100 and 500. 100’s (bottle): NDC 68462-179-01
500’s (bottle): NDC 68462-179-05
Store at 15° to 30°C (59° to 86°F) in well-closed containers.
Naproxen 500mg Tablets NDC 68462-190-05

Manufactured by:
Glenmark Generics Ltd
India Manufactured


Keep out of the reach of children


Sallus Pain Relief Collection

Rx Only USA

Contains:
30 Naproxen 500mg tablets
60ml Sallus Comfort Gel

Usual Dosage
For dosage recommendations and other important prescribing information, read accompanying insert.

Other Information
• Store at 20°C to 25°C (68°F to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]

Questions or Comments?
Call 1-888-535-2629 M-F, 9AM-5PM CST

Manufactured for:
Belmora LLC, PO Box 3063.
Arlington, VA 22203

October 2015

Distributed by: Sallus Labs
Sallus Laboratories, LLC
2700 Corporate Dr. Ste 200
Birmingham AL 35242

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:
• with longer use of NSAID medicines
• in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

NSAID medicines can cause ulcers and bleeding in the s stomach and intestines at any time during treatment.

Ulcers and bleeding:
• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:
• taking medicines called corticosteroids and
• anticoagulants
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

NSAID medicines should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Tell your healthcare provider:
• about all your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious Side Effects Include: Other side effects include:
• heart attack • stomach pain
• stroke • constipation
• high blood pressure • diarrhea
• heart failure from body swelling (fluid retention)

• gas

• kidney problems including kidney failure

• nausea

• bleeding and ulcers in the stomach and intestine • dizziness
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• liver problems including liver failure
• asthma attacks in people who have asthma

Get emergency help right away if you have 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 your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
• nausea
• there is blood in your bowel movement or it is black and sticky like tar
• more tired or weaker than usual
• itching
• your skin or eyes look yellow
• unusual weight gain
• stomach pain
• skin rash or blisters with fever
• flu-like symptoms
• swelling of the arms and legs, hands and feet
• vomit blood
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Belmora LLC at 1(888)535-2629.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Aspirin is an NSAID medicine 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 of these NSAID medicines 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.

NSAID medicines that need a prescription

Generic Name Trade name
Celecoxib Celebrex®
Diclofenac Cataflam® , Voltaren® , ArthrotecTM (combined with misoprostol)
Diflunisal Dolobid®
Etodolac Lodine® , Lodine® XL
Fenoprofen Nalfon® , Nalfon® 200
Flurbirofen Ansaid®
Ibuprofen Motrin® , Tab-Profen® , Vicoprofen® *(combined with hydrocodone),CombunoxTM (combined with oxycodone)
Indomethacin Indocin® , Indocin® SR, Indo-LemmonTM ,IndomethaganTM
Ketoprofen Oruvail®
Ketorolac Toradol®
Mefenamic Acid Ponstel®
Meloxicam Mobic®
Nabumetone Relafen®
Naproxen Naprosyn® , Anaprox® , Anaprox® DS,EC-Naproxyn® , Naprelan® , Naprapac® (copackaged with lansoprazole)
Oxaprozin Daypro®
Piroxicam Feldene®
Sulindac Clinoril®
Tolmetin Tolectin® , Tolectin DS® , Tolectin® 600

This Medication Guide has been approved by the U.S. Food and Drug Administration. Trademarks are the property of their respective owners.

Manufactured by:
Glenmark Generics Ltd
India

Manufactured for:
Belmora LLC
Arlington, VA 22203

Distributed by:
Sallus Laboratories, LLC
2700 Corporate Drive, Suite 200
Birmingham, AL 35242

Questions? 1 (888)535-2629Mon-Fri 9AM-5PM CST

October 2015

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