País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Haleon US Holdings LLC
TOPICAL
OTC DRUG
Arthritis pain reliever - for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body 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. - use only as directed - do not use more than directed or for longer than directed - apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes - do not apply in same area as any other product - do not apply with external heat such as heating pad - do not apply a bandage over the treated area - store ENCLOSED DOSING CARD with your Voltaren Arthritis Pain. The dosing card is re-usable.
New Drug Application
VOLTAREN ARTHRITIS PAIN- DICLOFENAC SODIUM GEL VOLTAREN ARTHRITIS PAIN- DICLOFENAC SODIUM HALEON US HOLDINGS LLC ---------- _DRUG FACTS_ _ACTIVE INGREDIENT_ Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug _PURPOSE_ Arthritis pain reliever _USES_ for the temporary relief of arthritis pain ONLY inthe 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. _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 small but 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 reaction to any other pain reliever or to a fever reducer for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgery on more than 2 body areas at the same time in th Leia o documento completo