6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in only about…

To receive this label RSS feed Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=00c56d8d-02e6-4839-86cc-00767428d5e9 To receive all DailyMed Updates for the last seven days Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/rss.cfm What will I get with the DailyMed RSS feed? DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such…

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.

Children under 12 years of age: consult physician.
Inactive Ingredients
Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication and Usage
For temporary relief of minor aches and pains.
…

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 Nonsteroidal 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…

During two randomized, double-blind placebo-controlled 12 week trials to evaluate the efficacy of naltrexone hydrochloride as an adjunctive treatment of alcohol dependence, most patients tolerated naltrexone hydrochloride well. In these studies, a total of 93 patients received naltrexone hydrochloride at a dose of 50 mg once daily. Five of these patients discontinued naltrexone hydrochloride because of nausea. No serious adverse events were reported during these two trials.
While extensive clinical studies evaluating the use of naltrexone hydrochloride in detoxified, formerly opioid-dependent individuals failed to identify any single, serious untoward risk of naltrexone hydrochloride use, placebo-controlled studies employing up to five-fold higher doses of naltrexone hydrochloride (up to 300 mg per day) than that recommended for use in opiate receptor blockade have…

Summary Company Announcement Date: February 24, 2020
FDA Publish Date: February 24, 2020
Product Type: Food & Beverages Soup Allergens Reason for Announcement: Recall Reason Description Product contains undeclared gluten
Company Name: Sierra Soups Brand Name: Brand Name(s) Sierra Soups
Product Description: Product Description Pasta e Fagioli
Company Announcement Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of “Pasta e Fagioli” because the soup mix contains an individually wrapped package of pasta, which contains gluten. However outer packaging states the product is Gluten Free. People who have allergies to gluten run the risk of serious or life-threatening…

To receive this label RSS feed Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=0794f32d-f9bd-460c-ba71-1bf9f68c109a To receive all DailyMed Updates for the last seven days Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/rss.cfm What will I get with the DailyMed RSS feed? DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such…

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

Nighttime Sleep-aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast
Alcohol-Free

Cherry Vanilla Flavor

Naturally and Artificially Flavor

Not for Pain, Not for Colds, Just for Sleep

12 FL. OZ. (354 ml)

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens.com ©2017 Walgreen Co.

Package Label for Nighttime Sleep-Aid

Package Label for Nighttime Sleep Aid Twin-Pack

…

TEAT DIPPING is an important part of a
MASTITIS CONTROL PLAN:

1. Dip teats immediately after milking.2. Use good milking and environmental management procedures.3. Use properly functioning milking equipment.4. Treat every quarter of every cow at dry off.5. Identify and treat or manage clinical cases promptly.6. Cull chronically infected cows.

TEAT DIPPING IN COLD WEATHER:
When the temperature falls below 10 degrees F, or when wind chill issignificant,special precautions should be taken to avoidchapped and frozen teats.1. Teats should be dry before turning cows out into cold weather.2. When teats are dipped after milking, allow 30 seconds contact,     and blot off any excess teat dip with a single service towel.3. Warm the teat dip to reduce drying time.4. Provide windbreaks in outside areas…

To receive this label RSS feed Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=09f03562-f0ee-4eb1-a7b7-fd0a8a0b51ad To receive all DailyMed Updates for the last seven days Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/rss.cfm What will I get with the DailyMed RSS feed? DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such…