Summary Company Announcement Date: December 04, 2019
FDA Publish Date: December 05, 2019
Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared Milk
Company Name: Nassau Candy Distributors Brand Name: Brand Name(s) Nancy Adams
Product Description: Product Description Dark Chocolate Graham Crackers
Company Announcement Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or lifethreatening allergic reactions if they consume this product….

Summary Company Announcement Date: December 02, 2019
FDA Publish Date: December 03, 2019
Product Type: Food & Beverages Fruit/Fruit Product Allergens Reason for Announcement: Recall Reason Description Undeclared sulfites and cyclamates
Company Name: Lin’s Waha Int’l Corp Brand Name: Brand Name(s) Lin’s Waha Int’l Corp
Product Description: Product Description Suantianyangmei Waxberry and Bingtangyangmei Waxberry
Company Announcement Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates. People who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they…

During its premarketing assessment, multiple doses of sertraline hydrochloride were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline hydrochloride varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder and PMDD.
Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that…

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=00652bb2-090c-4eaa-8fc2-e0be6913a724 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…

MEDICATION GUIDE

Terbinafine (ter-BIN-ah-fin)
hydrochloride tablets

What is the most important information I should know about terbinafine hydrochloride tablets?

Terbinafine hydrochloride tablets may cause serious side effects, including:

Liver problems that can lead to the need for a liver transplant or death . This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of liver problems:

Your doctor should do a blood test to check you for liver problems before you start treatment with terbinafine hydrochloride tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking terbinafine hydrochloride tablets if you develop liver problems.

What…

Inactive ingredients:
Sorbitol, Water, Glycerin, Cellulose Gum, Sodium Cocoyl Glutamate, Mentha Piperita (Peppermint) Oil, Sodium Chloride, Hydroxyapatite, Calcium Glycerophosphate, Bentonite, Glycyrrhiza Glabra (Licorice) Root Extract, Xylitol, Sodium Saccharin, Ascorbic Acid, Protease, Tocopheryl Acetate, Gentiana Lutea Root Extract, Sophora Angustifolia Root Extract, Lavandula Angustifolia (Lavender) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Scutellaria Baicalensis Root Extract, Propolis Extract, Krameria Triandra Root Extract, Commiphora Myrrha Oil, Menthol, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Silver …

1. General
Parenteral Drug Products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit.

2. Scratch, Prick or Puncture Testing Methods
There are two general methods of skin testing. (1) The skin is scarified first,
and the extract is then applied. (2) A drop of extract is put onto the skin,
and a prick or puncture is made through the drop. Avoid touching tip of dropper
to skin. Either method is satisfactory, but the second requires that the
instrument be cleansed between tests or that separate needles be used.
The extracts for scratch, prick or puncture testing are supplied
in dropper vials and should be kept in a rack or box in rows of 10 vials
corresponding to the rows of tests to…

INACTIVE INGREDIENTS
WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 20, GLYCERIN, POLYQUATERNIUM-10, SORBITAN MONOOLEATE, COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN, BUTYROSPERMUM PARKII (SHEA) OIL, DIMETHICONE, POLYAMIDE-3, SORBITAN STEARATE, CARBOXYMETHYCELLULOSE NA, ETHYLENEDIAMINE/STEARYL DIMER DILINOLEATE COPOLYMER, PG HYDROXYETHYLCELLULOSE STEARDIMONIUM CHLORIDE, SODIUM LAURYL GLUCOSE CARBOXYLATE, PHENOXYETHANOL, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, CAPRYLYL GLYCOL, TETRASODIUM EDTA, LAURYLDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDES CHLORIDE, GELLAN GUM, SODIUM ALGINATE, ARCTIUM LAPPA (BURDOCK ROOT) EXTRACT, LAURYL GLUCOSIDE, CAMELIA OLEIFERA (GREEN TEA) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, RUBEUS IDAEUS (RED RASPBERRY) OIL, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, CARRAGEENAN, CITRIC ACID, SODIUM CHLORIDE …

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages? Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. …

In five controlled studies in normal healthy subjects, the same daily doses of metoprolol succinate extended-release and immediate release metoprolol were compared in terms of the extent and duration of beta 1-blockade produced. Both formulations were given in a dose range equivalent to 100 to 400 mg of immediate release metoprolol per day. In these studies, metoprolol succinate extended-release was administered once a day and immediate release metoprolol was administered once to four times a day. A sixth controlled study compared the beta 1-blocking effects of a 50 mg daily dose of the two formulations. In each study, beta 1-blockade was expressed as the percent change from baseline in exercise heart rate following standardized submaximal exercise tolerance tests at steady…