Label: CURAHIST DM- dextromethorphan hbr, pyrilamine maleate liquid
- NDC Code(s): 83335-105-16
- Packager: Wittman Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 4, 2024
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DOSAGE & ADMINISTRATION
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
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WARNINGS
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 INGREDIENT
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INDICATIONS & USAGE
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
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CURAHIST DM
dextromethorphan hbr, pyrilamine maleate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83335-105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg in 5 mL PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 7.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POTASSIUM CITRATE (UNII: EE90ONI6FF) Product Characteristics Color Score Shape Size Flavor APPLE (Apple Pie) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83335-105-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/15/2024 Labeler - Wittman Pharma, Inc. (830980947) Establishment Name Address ID/FEI Business Operations Wittman Pharma, Inc. 830980947 analysis(83335-105) , label(83335-105) , manufacture(83335-105)