MIELIM Y MAS- dextromethorphan liquid 
Efficient Laboratories Inc.

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Drug Facts

Active Ingredient: (In each teaspoonful 5 mls)                   Purpose

Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

Cough Suppressant

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Do not use

Stop use and ask a doctor

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact the Poison Control Center right away.

If pregnant or breast-feeding,ask a health professional before use.

Directions:

Shake well immediately before use.

Do not exceed 4 doses in any 24 hour period.

Adults and Children 12 years and over - 10 ml (2 tsps) every 6 to 8 hours

Children 6 to under 12 years of age - 5 ml (1 tsp) every 6 to 8 hours

Children under 6 years of age - Consult a doctor

Temporarily relieves cough as may occur with the common cold or inhaled irritants.

Inactive Ingredients: Aspartame, Flavor, Honey,
Methylparaben, Potassium Sorbate, Propylene
Glycol, Propylparaben, Purified Water and Sodium
Chloride.

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com


Mielim

MIELIM Y MAS 
dextromethorphan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-295
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-295-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/199705/16/2023
2NDC:58593-295-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/1997
Labeler - Efficient Laboratories Inc. (969044932)
Registrant - Efficient Laboratories Inc. (969044932)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58593-295)

Revised: 5/2024
Document Id: 186c2d32-e8d3-d13d-e063-6294a90a2b0e
Set id: 711d1dae-3af4-46af-a3a8-cd827356a81a
Version: 6
Effective Time: 20240514
 
Efficient Laboratories Inc.