CHILDRENS ACETAMINOPHEN- childrens acetaminophen suspension
Pharmaceutical Associates, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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temporarily:
Liver warnings
This product contains acetaminophen. Severe liver damage may occur if your child takes
• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product, do not exceed the recommended dose (see overdose warning)
Stop use and ask a doctor if:
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present
These could be signs of a serious condition.
Weight (lb) | Age (yr) | Dose (mL)* |
---|---|---|
Under 24 | Under 2 years | ask a doctor |
24-35 | 2-3 years | 5 mL |
36-47 | 4-5 years | 7.5 mL |
48-59 | 6-8 years | 10 mL |
60-71 | 9-10 years | 12.5 mL |
72-95 | 11 years | 15 mL |
*or as directed by a doctor
NDC 0121-0946-05: 5 mL unit dose cup, in a tray of ten cups.
acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
CHILDRENS ACETAMINOPHEN
childrens acetaminophen suspension |
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Labeler - Pharmaceutical Associates, Inc. (044940096) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Pharmaceutical Associates, Inc. | 097630693 | manufacture(0121-0946) , label(0121-0946) |