Family Care Thera Flex Recall

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Questions & Answers

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Side Effects & Adverse Reactions

For external use only

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you:

• are 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using the product
• take more or for a longer time than directed

Do not use:

• on the face or rashes
• on wounds or damaged skin
• if allergic to aspirin or other NSAIDs
• with a heating pad
• when sweating (such as from exercise or heat)
• any patch from a pouch that has been open for 14 or more days
• right before or after heart surgery

Ask a doctor before use:

• if you are allergic to topical products
• the stomach bleeding warning applies to your
• you have high blood pressure, heart disease, or kidney disease
• you are taking a diuretic

Stop use and ask a doctor if:

• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
• rash, itching or skin irritation develops
• conditions worsens
• symptoms last for more than 3 days
• symptoms clear up and occur again within a few days
• stomach pain or upset gets worse or lasts

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Directions: Adult 18 years and older

• clean and dry affected area
• remove patch from backing film and apply to skin (see illustration)
• apply one patch to the affected area and leave in place for up to 8 to 12 hours
• if pains last after using the first patch, a second patch may be applied for up to another 8 to 12 hours
• only use on patch at a time
• do not use more than 2 patches per day
• do not use for more than 3 days in a row
• Children under 18 years of age: do not use

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History

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Other Information

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