Content about Paracetamol

June 10, 2013

Prestige Brands on Monday announced the launch of Goody's Headache Relief Shot. The product combines the pain relievers acetaminophen and caffeine in a fast-acting, single-dose liquid.

TARRYTOWN, N.Y. — Prestige Brands on Monday announced the launch of Goody's Headache Relief Shot. The product combines the pain relievers acetaminophen and caffeine in a fast-acting, single-dose liquid. 

May 15, 2013

The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

PITTSBURGH — The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

Mylan announced the approval of zolmitriptan tablets in the 2.5 mg and 5 mg strengths. The drug maker plans to launch the product immediately.

The drug is a generic version of IPR Pharmaceuticals' Zomig and is used for the acute treatment of migraine in adults. Various versions of the drug had sales of $152.8 million during the 12-month period that ended in March, according to IMS Health.

 

May 2, 2013

The National Alliance for Hispanic Health on Thursday announced a partnership with the Acetaminophen Awareness Coalition to increase awareness among Spanish-speaking consumers for the importance of safe use of medicines that contain acetaminophen.

WASHINGTON — The National Alliance for Hispanic Health on Thursday announced a partnership with the Acetaminophen Awareness Coalition to increase awareness among Spanish-speaking consumers for the importance of safe use of medicines that contain acetaminophen. Many Hispanic consumers are not aware of any health risks associated with taking too much acetaminophen and do not check to see if their medicines contain acetaminophen, a drug ingredient in more than 600 over-the-counter and prescription medicines, according to Community Panel Discussions recently conducted by the Alliance.

April 16, 2013

The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

DUBLIN — The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of the 200-mg strength of Doryx (doxycycline hyalite) delayed-release tablets, which the company plans to release in July 2013.

Doryx delayed-release tablets are already available in the 75-mg, 100-mg and 150-mg strengths.

 

April 2, 2013

A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

March 4, 2013

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.

Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.

January 31, 2013

A standards-development organization for the pharmacy services industry has updated a white paper on protecting consumers and patients from accidental overdoses of the painkiller acetaminophen.

SCOTTSDALE, Ariz. — A standards-development organization for the pharmacy services industry has updated a white paper on protecting consumers and patients from accidental overdoses of the painkiller acetaminophen.

The NCPDP announced the updated white paper, "NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen Version 1.1."

November 12, 2012

Procter & Gamble and Teva Pharmaceutical on Monday gained European Union approval for a joint venture on the sale of nonprescription medicines to be called PGT Healthcare, according to published reports.

CINCINNATI — Procter & Gamble and Teva Pharmaceutical on Monday gained European Union approval for a joint venture on the sale of nonprescription medicines to be called PGT Healthcare, according to published reports. 

According to the reports, the joint venture didn't raise competition concerns. P&G will have a 51% stake in the venture. 

 

 

October 26, 2012

As many as 97% of parents are confident they administered the correct dose of acetaminophen to their sick child when using AccuDial Pharmaceutical's weight-based dosing label, according to research published earlier this year.

PALM BEACH GARDENS, Fla. — As many as 97% of parents are confident they administered the correct dose of acetaminophen when using AccuDial Pharmaceutical's weight-based dosing label, according to research published earlier this year.

October 15, 2012

Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received Food and Drug Administration approval on its abbreviated new drug application for irbesartan tablets — the generic equivalent to Sanofi's Avapro — in the 75-mg, 150-mg and 300-mg strengths.

PARSIPPANY, N.J. — Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received Food and Drug Administration approval on its abbreviated new drug application for irbesartan tablets — the generic equivalent to Sanofi's Avapro — in the 75-mg, 150-mg and 300-mg strengths.

October 5, 2012

AccuDial Pharmaceutical earlier this year introduced five SKUs across its Children’s AccuDial Acetaminophen Oral Suspension, featuring one of the only weight-based dosing acetaminophen products with an interactive, rotating label.

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical earlier this year introduced five SKUs across its Children’s AccuDial Acetaminophen Oral Suspension, featuring one of the only weight-based dosing acetaminophen products with an interactive, rotating label. The single-ingredient products, indicated to help reduce fever in children, are timely for the coming cough-cold season. Children's AccuDial Acetaminophen Oral Suspension will retail for a suggested $4.99 and is available in five flavors: grape, dye-free cherry, cherry, bubble gum and strawberry. 

September 25, 2012

Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

The drug maker announced the recall of hydrocodone bitartrate and acetaminophen tablets in the 10 mg/500 mg strengths based on a customer complaint of tablets that were thicker and darker-colored than the others.

September 14, 2012

The Food and Drug Administration has granted regulatory approval for a generic drug to treat tension headaches.

PHILADELPHIA — The Food and Drug Administration has granted regulatory approval for a generic drug to treat tension headaches.

Lannett announced the approval of butalbital, acetaminophen and caffeine tablets in the 50-mg/325-mg/40-mg strength. the drug is a generic version of Watson Pharmaceuticals' Fioricet.

Branded and generic versions of the drug had sales of $30 million during the 12-month period ended in July, including $15 million for branded Fioricet. Lannett plans to start shipping its version next month, the company said.

September 4, 2012

Bayer HealthCare's Consumer Care Division on Tuesday introduced Bayer Migraine Formula, an over-the-counter medication designed to relieve migraine pain and accompanying symptoms like nausea, phonophobia (sound sensitivity) and photophobia (light sensitivity) through a formulation of aspirin, acetaminophen and caffeine.

MORRISTOWN, N.J. — Bayer HealthCare's Consumer Care Division on Tuesday introduced Bayer Migraine Formula, an over-the-counter medication designed to relieve migraine pain and accompanying symptoms like nausea, phonophobia (sound sensitivity) and photophobia (light sensitivity) through a formulation of aspirin, acetaminophen and caffeine.

July 24, 2012

Significant product recalls and the ongoing recession have driven consumer behavior change in the OTC aisle, according to a new report published Tuesday by Kline.

PARSIPPANY, N.J. — Significant product recalls and the ongoing recession have driven consumer behavior change in the OTC aisle, according to a new report published Tuesday by Kline. In addition, road blocks to savings, such as reimbursement of OTC medicines under flexible spending accounts, were recently put in place with the new requirement that those medicines now to be prescribed by a physician in order to qualify for reimbursement. Approximately 1-in-5 respondents have used FSAs to purchase OTC drugs or nutritional supplements in the past, the report noted.

June 28, 2012

A new continuing-education program offered by a national pharmacist professional organization aims to prepare pharmacists to communicate with patients about the safe and effective use of the painkiller acetaminophen.

WASHINGTON — A new continuing-education program offered by a national pharmacist professional organization aims to prepare pharmacists to communicate with patients about the safe and effective use of the painkiller acetaminophen.

The American Pharmacists Association said its new CE program would allow pharmacists to outline the Food and Drug Administration's recent advisory panel meetings on the drug, communicate with patients about its appropriate use, and engage consumers in dialogue and such activities as reading labels of products containing acetaminophen.

December 23, 2011

The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants. Giving more than the recommended dose of acetaminophen can cause serious side effects and possibly death, the agency warned.

December 1, 2011

Actavis is in the process of bringing FeverAll acetaminophen suppositories back to the market, the company announced. FeverAll had been unavailable while changes were being made at the product's manufacturing facility.

MORRISTOWN, N.J. — Actavis is in the process of bringing FeverAll acetaminophen suppositories back to the market, the company announced. FeverAll had been unavailable while changes were being made at the product's manufacturing facility.

November 14, 2011

The Food and Drug Administration has approved a generic drug for treating pain.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for treating pain.

Qualitest Pharmaceuticals announced Monday the approval of acetaminophen and codeine phosphate oral solution in the 120-mg/12-mg-per-5-mL strength.

Sales for acetaminophen and codeine phosphate oral solution for $4.3 million during the 12-month period ended in September, according to IMS Health.

October 5, 2011

AccuDial Pharmaceutical on Tuesday acquired Stephen Key Design in a move that will expand AccuDial’s patent portfolio to more than 50 patents for weight-based dosing and other extended content rotating labels, which add 75% more labeling space to a container.

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical on Tuesday acquired Stephen Key Design in a move that will expand AccuDial’s patent portfolio to more than 50 patents for weight-based dosing and other extended content rotating labels, which add 75% more labeling space to a container.

August 8, 2011

Uniform concentrations of single-ingredient liquid pediatric acetaminophen medicines have been making their way to the shelf as promised by the Consumer Healthcare Products Association earlier this year, as evidenced by these new product facings from PediaCare and Triaminic.

WASHINGTON — Uniform concentrations of single-ingredient liquid pediatric acetaminophen medicines have been making their way to the shelf as promised by the Consumer Healthcare Products Association earlier this year, as evidenced by these new product facings from PediaCare and Triaminic. Note, too, that both new formulations feature uniform age-appropriate dosing devices, in this case syringes.

July 29, 2011

Prestige Brands on Thursday announced the launch of its new PediaCare and Little Remedies single-concentration acetaminophen products.

IRVINGTON, N.Y. — Prestige Brands on Thursday announced the launch of its new PediaCare and Little Remedies single-concentration acetaminophen products.

The new standard concentration liquid acetaminophen products for infants and children under 2 years of age will be 160 mg/5 mL.

“The voluntary changes to single-concentration acetaminophen dosing demonstrate the continued commitment to accuracy, safety and innovation from PediaCare and Little Remedies," Prestige VP over-the-counter products Albert Hwang said.

July 28, 2011

McNeil Consumer Healthcare on Thursday announced plans for new dosing instructions, lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from eight pills per day (4,000 mg) to six pills per day (3,000 mg).

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday announced plans for new dosing instructions, lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from eight pills per day (4,000 mg) to six pills per day (3,000 mg).

July 22, 2011

The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

ROCKVILLE, Md. — The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

“You’re in the drug store, looking for a fever-reducing medicine for your children,” the message begins. “They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.”

May 19, 2011

Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

SILVER SPRING, Md. — Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.