Label: MIELIM Y MAS- dextromethorphan liquid
- NDC Code(s): 58593-295-04, 58593-295-06
- Packager: Efficient Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 14, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
-
DO NOT USE
Do not use
- 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.
- 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.
Stop use and ask a doctor
- if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MIELIM Y MAS
dextromethorphan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-295 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) HONEY (UNII: Y9H1V576FH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-295-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/1997 05/16/2023 2 NDC:58593-295-06 178 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/01/1997 Labeler - Efficient Laboratories Inc. (969044932) Registrant - Efficient Laboratories Inc. (969044932) Establishment Name Address ID/FEI Business Operations Dextrum Laboratories Inc. 007392322 manufacture(58593-295)