AAA MOUTH & THROAT
Main information
- Trade name:
- AAA MOUTH & THROAT
- Active ingredient:
- BENZOCAINE
- Available from:
- Rorer Pharmaceuticals Limited
- Dosage:
- 1.5/.0413 Milligram
- Pharmaceutical form:
- Oromucosal Spray
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Ireland
- Language:
- English
Other information
Status
- Source:
- HPRA - Health Products Regulatory Authority - Ireland
- Authorization number:
- PA0468/019/001
- Authorization date:
- 01-04-1990
- Last update:
- 14-10-2016
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- Access to this document is only available to registered users.
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30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen
Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.
FDA - U.S. Food and Drug Administration
23-1-2019

Foot and mouth disease
Foot and mouth disease (FMD) is a highly contagious viral infection that is not transmissible to humans. It remains one of the main concerns of livestock farmers and health authorities, due to its potentially huge socio-economic impact. Below is a detailed review of ANSES’s work on FMD.
France - Agence Nationale du Médicament Vétérinaire
20-12-2018

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
FDA - U.S. Food and Drug Administration
18-12-2018

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
[07-26-2016] The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection).
FDA - U.S. Food and Drug Administration
31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle
ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...
FDA - U.S. Food and Drug Administration
3-7-2018

Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE, Foot-and-mouth disease vaccine (inactivated) (multistrain: 1-3 strains out of set of 8), Revision: 4, Authorised
Europe - EMA - European Medicines Agency
29-6-2018

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo
FDA is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo, a prescription gel that is given to dogs by mouth to treat noise aversion.
FDA - U.S. Food and Drug Administration
19-6-2018

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks
Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
FDA - U.S. Food and Drug Administration
24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats
The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.
FDA - U.S. Food and Drug Administration
23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit
OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
FDA - U.S. Food and Drug Administration
23-5-2018

Do Teething Babies Need Medicine on Their Gums? No
Teething is a normal part of childhood that doesn’t need a 'cure' with prescription or over-the-counter (OTC) medications. FDA warns parents that benzocaine products are not safe for treating teething in children. There are safer, non-toxic alternatives.
FDA - U.S. Food and Drug Administration
23-5-2018

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder
Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.
FDA - U.S. Food and Drug Administration
22-5-2018

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics
FDA is taking safety actions regarding over-the-counter benzocaine oral drug products and prescription local anesthetics.
FDA - U.S. Food and Drug Administration
21-5-2018

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls
Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity
FDA - U.S. Food and Drug Administration
18-5-2018

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls
MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.
FDA - U.S. Food and Drug Administration
24-4-2018

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella
Health Canada is advising Canadians that one lot of “Throat Coat Lemon Echinacea” herbal tea is being voluntarily recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). An infection caused by Salmonella bacteria may pose serious health risks, particularly for young children, pregnant women, the elderly and people with weak immune systems.
Health Canada
14-1-2019

Submissions received: Benzocaine: proposed advisory statements for medicines
Submissions received on the Benzocaine: proposed advisory statements for medicines have been published
Therapeutic Goods Administration - Australia
14-1-2019

Consultation: Benzocaine: proposed advisory statements for medicines
The TGA is seeking comments on proposed new required label statements for medicines containing benzocaine. Closing date: 16 October 2018
Therapeutic Goods Administration - Australia
9-1-2019

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1
Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1
Europe - EMA - European Medicines Agency
19-6-2018

Aftovaxpur Doe (Merial)
Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8
Europe -DG Health and Food Safety