Addiction, Abuse, and Misuse
Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone bitartrate, a Schedule II controlled substance. As an opioid, hydrocodone and acetaminophen tablets exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing hydrocodone bitartrate and acetaminophen tablets, and monitor all patients receiving hydrocodone bitartrate and acetaminophen tablets for the development of these behaviors or conditions. Risks are increased in patients with a personal or…

Summary Company Announcement Date: January 17, 2018
FDA Publish Date: January 19, 2018
Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared peanut
Company Name: Palmer Candy Company Brand Name: Brand Name(s) Palmer Bakery Delights
Product Description: Product Description Sea Salt Caramel Hearts
Company Announcement Palmer Candy Company (www.palmercandy.com), announced today a limited recall of Sea Salt Caramel Hearts that were only sold at Bomgaars Supply Inc. Store in the Midwest States. The voluntary recall, in cooperation with the U.S. Food and Drug Administration (FDA) due to abundance of caution of a possible peanut allergen contamination….

                                          
Display Panel CONTAC Cold+Flu Night Caplets: 24 count Package

NIGHT

CONTAC®
COLD+FLU

Phenylephrine HCl, Acetaminophen, Chlorpheniramine Maleate
Nasal Decongestant/Pain Reliever-Fever Reducer/Antihistamine

See new warning

Maximum Strength
Multi-Symptom

Nasal Congestion • Sinus Pressure
Sore Throat • Head & Body Aches
Fever • Runny Nose • Sneezing

24 CAPLETS

Retain outer carton for complete directions and warnings.

TAMPER-EVIDENT PACKAGING FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.
Distributed by:Mylan Consumer Healthcare, Inc.,Morgantown, WV 26505 Made in Canada
CONTAC® is a registered trademark of Meda AB, a Mylan Company© Mylan, Inc. www.contac.com UC402324-06-03

…

LADY SPEED STICK TEEN SPIRIT PINK CRUSH- aluminum zirconium tetrachlorohydrex gly stick 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=04bf30f9-7472-4caa-a317-d8c52b4b261b 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…

The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride tablets have been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride tablets not be used concomitantly with an MAOI.

Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.
Serotonin…

8.1 Pregnancy

Risk Summary

The data on use of buprenorphine, the active ingredient in Buprenorphine Sublingual Tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data]. Observational studies have reported on congenital malformations among buprenorphine-exposed pregnancies, but were also not designed appropriately to assess the risk of congenital malformations specifically due to buprenorphine exposure [see Data].
Reproductive and developmental studies in rats and rabbits identified adverse events at clinically relevant and higher doses. Embryofetal death was observed in both rats and rabbits administered…

Allergy alert
Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Heart alert
Taking more than directed can cause serious heart problems or death

Do not use if you have bloody or black stool

Ask a doctor before use if you have

fever
mucus in the stool
a history of liver disease
a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are taking a prescription drug.
Loperamide may interact with certain prescription drugs.

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

symptoms get worse
diarrhea lasts for more than 2 days
you get abdominal swelling or bulging.These may be…

Elaeis Guineensis (Palm) Kernel Oil, Stearyl Alcohol, Cyclomethicone, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Hydrogenated Soybean Oil, PEG-8 Distearate, Parfum, Behenyl Alcohol, Citric Acid, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate …

anhydrous lactose, crospovidone, D&C red no. 7 calcium lake, ethylcellulose aqueous dispersion, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, mannitol, mineral oil, natural and artificial berry type flavor, polysorbate 80, sodium metabisulfite, sucralose, talc, triethyl citrate …

General: The safety and effectiveness of local anesthetics depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use (See WARNINGS, ADVERSE REACTIONS, and OVERDOSAGE). During major regional nerve blocks, the patient should have intravenous fluids running via an indwelling catheter to assure a functioning intravenous pathway. The lowest dosage of local anesthetic that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

Epidural Anesthesia: During epidural administration of MARCAINE, 0.5% and 0.75% solutions should be…