The Food and Drug Administration has issued a statement urging consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose.
A less concentrated form of the popular medication is arriving on store shelves, the FDA noted, and giving too much acetaminophen can cause serious side effects and possibly death. Giving too little can cause the medication to be ineffective.
To reduce the confusion over different strengths, some manufacturers are voluntarily offering only the less concentrated version for all children. Until now, liquid acetaminophen marketed specifically for infants has been available only in a stronger concentration.
For now, both concentrations of liquid acetaminophen are in circulation. Before giving the medication, parents and caregivers should know whether they have the less concentrated version or the older, more concentrated medication. The FDA expressed concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused.
The FDA called for parents and caregivers to take the following steps:
• Read the Drug Facts label on the package carefully to identify the concentration of the liquid acetaminophen, the correct dosage and the directions for use.
• Do not depend on a banner proclaiming that the product is "new." Some medicines with the old concentration also have this headline on their packaging.
• Use only the dosing device provided with the purchased product to correctly measure the right amount of liquid acetaminophen.
• Consult a pediatrician before giving this medication and make sure the pediatrician and the parent or caregiver are talking about the same concentration.
Parents and caregivers should understand that there is no dosing amount specified for children younger than 2 years. Those with an infant or child younger than 2 should always check with the child's healthcare provider for dosing instructions, according to the FDA.
An April 2011 report from FDA's Center for Drug Evaluation and Research found that confusion caused by the different concentrations of liquid acetaminophen for infants and children was leading to overdoses that made infants seriously ill, with some dying from liver failure.
To avoid dosing errors, some manufacturers voluntarily changed the liquid acetaminophen marketed for infants from 80 mg per 0.8mL or 80 mg per 1 mL to be the same concentration as the liquid acetaminophen marketed for children — 160 mg per 5mL. This less concentrated liquid acetaminophen marketed for infants has new dosing directions and may have a new dosing device in the box, such as an oral syringe.
But this change is voluntary, and some of the older, stronger concentrations of acetaminophen marketed for infants are still available and may remain available.
Acetaminophen is marketed for infants under brand names such as Little Fevers Infant Fever/Pain Reliever, Pedia Care Fever Reducer Pain Reliever and Triaminic Infants' Syrup Fever Reducer Pain Reliever. There are also store brands on the shelves.
A less concentrated form of the popular medication is arriving on store shelves, the FDA noted, and giving too much acetaminophen can cause serious side effects and possibly death. Giving too little can cause the medication to be ineffective.
To reduce the confusion over different strengths, some manufacturers are voluntarily offering only the less concentrated version for all children. Until now, liquid acetaminophen marketed specifically for infants has been available only in a stronger concentration.
For now, both concentrations of liquid acetaminophen are in circulation. Before giving the medication, parents and caregivers should know whether they have the less concentrated version or the older, more concentrated medication. The FDA expressed concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused.
The FDA called for parents and caregivers to take the following steps:
• Read the Drug Facts label on the package carefully to identify the concentration of the liquid acetaminophen, the correct dosage and the directions for use.
• Do not depend on a banner proclaiming that the product is "new." Some medicines with the old concentration also have this headline on their packaging.
• Use only the dosing device provided with the purchased product to correctly measure the right amount of liquid acetaminophen.
• Consult a pediatrician before giving this medication and make sure the pediatrician and the parent or caregiver are talking about the same concentration.
Parents and caregivers should understand that there is no dosing amount specified for children younger than 2 years. Those with an infant or child younger than 2 should always check with the child's healthcare provider for dosing instructions, according to the FDA.
An April 2011 report from FDA's Center for Drug Evaluation and Research found that confusion caused by the different concentrations of liquid acetaminophen for infants and children was leading to overdoses that made infants seriously ill, with some dying from liver failure.
To avoid dosing errors, some manufacturers voluntarily changed the liquid acetaminophen marketed for infants from 80 mg per 0.8mL or 80 mg per 1 mL to be the same concentration as the liquid acetaminophen marketed for children — 160 mg per 5mL. This less concentrated liquid acetaminophen marketed for infants has new dosing directions and may have a new dosing device in the box, such as an oral syringe.
But this change is voluntary, and some of the older, stronger concentrations of acetaminophen marketed for infants are still available and may remain available.
Acetaminophen is marketed for infants under brand names such as Little Fevers Infant Fever/Pain Reliever, Pedia Care Fever Reducer Pain Reliever and Triaminic Infants' Syrup Fever Reducer Pain Reliever. There are also store brands on the shelves.
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