Label: ROMPE PECHITO DM FOR KIDS- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 58593-276-04
- Packager: Efficient Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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Warnings
Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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.
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Do not use
Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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.
- Keep out of reach of children.
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Directions
Do not give more than 6 doses in any 24 hours period shake well before use measure only with dosing cup provided keep dosing cup with product mL = milliliter
Age Dose
Children 6 to under 12 years of age 5 mL every 4 hours
Children 4 to under 6 years of age 2.5 mL every 4 hours
Children under 4 years of age Do not use
- Inactive Ingredients:
- QUESTIONS
- Stop use and ask a doctor if
- Ask a doctor before use if the child has
- Other Information
- Rompe Pechito
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INGREDIENTS AND APPEARANCE
ROMPE PECHITO DM FOR KIDS
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-276 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 2.5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 2.5 mL Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) AMERICAN ELDERBERRY (UNII: 7610Y219OC) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) HONEY (UNII: Y9H1V576FH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) ZINC SULFATE (UNII: 89DS0H96TB) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-276-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/01/2023 Labeler - Efficient Laboratories Inc (969044932) Registrant - Efficient Laboratories Inc (969044932) Establishment Name Address ID/FEI Business Operations Rnv LLC 118917568 manufacture(58593-276)