Dosage Form: oral solution
AccuHist PDX Drops - chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride solution
Active Ingredients (per 1 mL)
Chlorpheniramine maleate 1 mg
Dextromethorphan hydrobromide 2.5 mg
Phenylephrine hydrochloride 2.5 mg
Purpose
Antihistamine
Cough Suppressant
Nasal Decongestant
Uses
Temporarily relieves:
- runny nose
- reduces sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies
- nasal congestion due to the common cold
- cough due to minor throat and bronchial irritation associated with the common cold.
- Temporarily restores free breathing through the nose.
Warnings
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 give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucous) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult 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.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Directions
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.
Other Information
Store at 20°-25°C (68°-77°F).
Under Federal Law, this product is available without a prescription. Certain laws may differ.
Inactive Ingredients
bubble gum flavor, citric acid, glycerin 99.5% min, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol 70% solution.
Questions? Comments?
Call 1-678-208-0388
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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 | 04/30/2013 |
| Labeler - Tiber Laboratories, LLC (008913939) |
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