The following Structured Product Label (SPL) was submitted to the FDA by Wittman Pharma, Inc. for the product Curahist Dm (NDC 83335-105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions: Do not exceed the recommended dosage.
Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not
To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not
to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age - consult a doctor
Warnings
Do not exceed recommended dosage.
■ a persistent cough may be a sign of a serious condition.
If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.
Do not use this product
■ if you are now taking a prescription monoamine oxidase inhibitor (MADI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MADI drug. If you do not know if your prescription drug contains an MADI, ask a doctor or pharmacist before taking this product
■ for persistent or chronic cough such as occurs with
smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm(mucus) unless directed by a doctor
Ask a doctor before use if you have
■ a breathing problem such as emphysema or chronic bronchitis ■glaucoma ■difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if you are taking sedatives or tranquilizers.
When using this product
■ excitability may occur, especially in children ■may cause marked drowsiness ■ sedatives and tranquilizers may increase drowsiness effect ■avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.
Inactive ingredients: Citric acid, flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose
Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
■ runny nose ■sneezing ■itching of the nose or throat
■ itchy, watery eyes ■cough due to minor throat and bronchial irritation associated with a cold ■alleviates cough to help you sleep ■nonnarcotic cough suppressant for the relief of cough
Keep out of reach of children.
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Antitussive/Antihistamine
Active Ingredients (in each 5 ml teaspoonful)
Dextromethorphan HBr 7.5mg
Pyrilamine Maleate 7.5mg
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