MIELIM Y MAS- dextromethorphan liquid 
Efficient Laboratories Inc.

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.

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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 finalpart34102/01/1997
Labeler - Efficient Laboratories Inc. (969044932)
Registrant - Efficient Laboratories Inc. (969044932)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58593-295)

Revised: 5/2023
Document Id: fbd315ee-745c-8fdd-e053-6394a90aab67
Set id: 711d1dae-3af4-46af-a3a8-cd827356a81a
Version: 5
Effective Time: 20230516
 
Efficient Laboratories Inc.