Label: CURATUSSIN DM- dextromethorphan hbr/guaifenesin liquid
- NDC Code(s): 83335-102-04, 83335-102-08, 83335-102-16
- Packager: Wittman Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 8, 2024
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- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
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WARNINGS
Warnings: Do not use 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 MAOI; ask a doctor or pharmacist before taking this product.t
Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic, such as occurs with smoking, asthma,
chronic bronchitis, or emphysema
Stop use and ask doctor if
■cough lasts more than 7 days., comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
■you are hypersensitive to any of the ingredients.If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. - INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CURATUSSIN DM
dextromethorphan hbr/guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83335-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) PROPYLPARABEN (UNII: Z8IX2SC1OH) POTASSIUM CITRATE (UNII: EE90ONI6FF) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83335-102-16 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2024 2 NDC:83335-102-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2024 3 NDC:83335-102-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/01/2024 Labeler - Wittman Pharma, Inc. (830980947) Establishment Name Address ID/FEI Business Operations Wittman Pharma, Inc. 830980947 analysis(83335-102) , manufacture(83335-102) , label(83335-102)