Aleve Arthritis Pain Gel 1 mg/g

Diclofenac Sodium · GEL · Bayer HealthCare LLC

No Recall History

Plain English

Aleve Arthritis Pain Gel is a gel containing diclofenac sodium at 1 mg/g, taken topical. Manufactured by Bayer HealthCare LLC.

Key Facts

Brand Name: Aleve Arthritis Pain Gel
Generic Name: Diclofenac Sodium
NDC Code (Product): 0280-0039
Manufacturer: Bayer HealthCare LLC
Strength: 1 mg/g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Application #: ANDA211253
Marketing Start: 06/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective7,500 reports

pain7,261 reports

fatigue6,865 reports

rheumatoid arthritis6,257 reports

rash5,933 reports

abdominal discomfort5,905 reports

systemic lupus erythematosus5,737 reports

alopecia5,681 reports

pemphigus5,566 reports

glossodynia5,565 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Dosage & Administration

Directions Use up to 21 days unless directed by your doctor. Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain : Use 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist or elbow)-Squeeze out 2.25 inches (2 grams) For each lower body (foot, ankle or knee)-Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed do not use more than directed for longer than directed apply to only clean, dry skin that does not have cuts, open wounds, infections or rashes do not apply in the same area as any other product do not apply with external heat such as heating pad do not apply to bandage over the treated area store ENCLOSED DOSING CARD with your ALEVE Arthritis Pain. The dosing cards is re-usable.

Warnings

For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening blisters facial swelling shock rash If an allergic reaction occurs, stop use and seek medical help right away. Liver Warning : This product contains diclofenac. Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac 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 apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reacti…

Frequently Asked Questions

What is Aleve Arthritis Pain Gel used for?

Aleve Arthritis Pain Gel contains Diclofenac Sodium. It is a gel taken topical. Consult your doctor for specific uses.

Is Aleve Arthritis Pain Gel a controlled substance?

Aleve Arthritis Pain Gel is not classified as a controlled substance by the DEA.

What is the generic name for Aleve Arthritis Pain Gel?

The generic name for Aleve Arthritis Pain Gel is Diclofenac Sodium. There are 12 other brand versions of Diclofenac Sodium.

What is the NDC code for Aleve Arthritis Pain Gel 1 mg/g?

The NDC (National Drug Code) for Aleve Arthritis Pain Gel 1 mg/g is 0280-0039, listed by Bayer HealthCare LLC.

Product NDC

0280-0039

Package NDC

0280-0039-01

Other Diclofenac Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)