NUDROXIPAK I-800- ibuprofen,methyl salicylate/menthol/capsaicin kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

CAPSAICIN

Composition:

CAPSAICIN 0.25 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted. IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen. IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PR

Product summary:

IBU tablets are available in the following strengths, colors and sizes: 800 mg (white, caplet, debossed 8I) Bottles of 100 NDC 55111-684-01 Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured by: Dr. Reddy’s Laboratories Louisiana, LLC Shreveport, LA 71106 USA Revised, July 2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NUDROXIPAK I-800- IBUPROFEN,METHYL SALICYLATE/MENTHOL/CAPSAICIN
NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What it the most important information I should know about medicines
called Non-Steroidal 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 use 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 NSAIDs?
Do not take NSAIDs:
• if you 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 ab

Summary of Product characteristics

NUDROXIPAK I-800- IBUPROFEN,METHYL SALICYLATE/MENTHOL/CAPSAICIN
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
NUDROXIPAK I-800 PAIN RELIEF PAK
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MELOXICAM TABLETS USP.
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MELOXICAM
TABLETS USP.
MELOXICAM TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Use or the temporary relief of minor aches and muscle pains associated
with arthritis, simple backache,
strains, muscle soreness and stiffness. (15)
WARNINGS AND PRECAUTIONS
For external use only. Use only as directed. Avoid contact with eyes
and mucous membranes or genitals.
Do not cover or tightly bandage area.
on wounds or damaged skin.
Do not use with heating pad. (16)
DOSAGE AND ADMINISTRATION
Shake before each use. Prior to first use rub small amount to check
for sensitivity. Apply product directly
to affected area. Dry before contact with clothes or bedding to avoid
staining. Wash hands after use.
Product may be used as necessary, but should not be used more than
four times per day. (20)
STORE BELOW (90°F/32°C) (20)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 11/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
BOXED WARNING
DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
CARDIOVASCULAR EFFECTS
PRECAUTIONS
GENERAL
HEPATIC EFFECTS
HEMATOLOGICAL EFFECTS
PREEXISTING ASTHMA
OPHTHALMOLOGICAL EFFECTS.
ASEPTIC MENINGITIS
INFORMATION FOR PATIENTS
LABORATORY TESTS
DRUG INTERACTIONS
DIURETICS
LITHIUM
METHOTREXATE
WARFARIN-TYPE ANTICOAGULANTS
H-2 ANTAGONISTS
PREGNANCY
ADVERSE REACTIONS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic
disease:
MILD TO MODERATE PAIN:
DYSMENORRHEA:
HOW SUPPLIED
*
FULL PRESCRIBING INFORMATION
BOXED WARNING
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of
serious cardiovascular thrombotic e