ACCUHIST
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chlorpheniramine maleate and
phenylephrine hydrochloride solution
Tiber Laboratories, LLC
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 relieves:
Do not exceed recommended dosage.
If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
May cause excitability, especially in children.
May cause drowsiness; sedatives and tranquilizers may increase this effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.
Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.
Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.
In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Children 6 to 12 years of age: 2 mL every 4 hours
Children under 6 years of age: Consult a physician.
Do not exceed 6 doses during a 24-hour period or as directed by a physician.
Store at 20°-25°C (68°-77°F).
Under Federal Law, this product is available without a prescription. Certain laws may differ.
cherry flavor, citric acid, glycerin 99.5% min, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol 70% solution.
ACCUHIST
chlorpheniramine maleate, phenylephrine hydrochloride solution |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part341 | 01/25/2010 |
Labeler - Tiber Laboratories, LLC (008913939) |
Revised: 07/2011 Tiber Laboratories, LLC