Label: GILTUSS DIABETIC DM- dextromethorphan hbr solution
- NDC Code(s): 58552-149-04
- Packager: Gil Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2023
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ACTIVE INGREDIENT
Drug Facts
Active Ingredient (In each 10 mL) Purpose
Dextromethorphan HBr. 30 mg ......................... Cough Suppresant
Uses
- temporarily relieves:
- cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- temporarily relieves:
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WARNINGS
Warnings
Do not use
- if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- When using this product do not use more than directed.
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INDICATIONS & USAGE
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if
cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as these could be signs of a serious condition.
- PURPOSE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GILTUSS DIABETIC DM
dextromethorphan hbr solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-149 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 10 mL Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58552-149-04 1 in 1 CARTON 08/09/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/09/2023 Labeler - Gil Pharmaceutical Corp (176826592) Establishment Name Address ID/FEI Business Operations SEAWAY PHARMA 117218785 analysis(58552-149) , manufacture(58552-149) , pack(58552-149)
