Cold Medicine XL-3 for Children
Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-700
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.
Acetaminophen 80 mg
Chlorpheniramine Maleate 2 mg
Phenylepherine Hydrochloride 5 mg
Analgesic
Antihistamine
Decongestant
Do not exceed recommended dosage because at higher dosages nervousness, dizziness, or sleeplessness may occur. Do not give the product for more than 5 days.
If symptoms persist, or if new ones occur consult a doctor.
If fever persists for more than 3 days (72 hours), or recurs, consult a doctor.
Drink water with each dose
Do not give this product at least after 7 days after a tonsillectomy or oral surgery, unless directed by a doctor.
May cause drowsiness
Do not give to children who have asthma or glaucoma, unless directed by a doctor.
Do not give this product to children who have heart disease, high blood pressure, thyroid disease or diabetes, unless directed by a doctor.
Do not give this product to a child who is taking a prescription drug for high blood pressure or depression, without first consulting a doctor
Directions Children 6 years of age to under 12 years: take 1 tablet every 4 hours, do not take more than 6 tablets in 24 hours, unless directed by a doctor. Children under 6 years of age, consult a doctor
Inactive Ingredients DC Red No. 33, FDC Blue No. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water
COLD MEDICINE
XL-3 FOR CHILDREN
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet, chewable |
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Labeler - Selder, S.A. de C.V. (824413629) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Selder, S.A. de C.V. | 824413629 | manufacture |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.