Label: MIELIM Y MAS- dextromethorphan liquid
- NDC Code(s): 58593-295-04, 58593-295-06
- Packager: Efficient Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 16, 2023
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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 final part341 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)
