MIELIM Y MAS

Main information

  • Trade name:
  • MIELIM Y MAS- dextromethorphan liquid
  • Composition:
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MIELIM Y MAS- dextromethorphan liquid
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Cough Suppressant 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. Temporarily relieves cough as may occur with the common cold or inhaled irritants.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 58593-295-04, 58593-295-06
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

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.

----------

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

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.

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 Y MAS

dextromethorphan liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 59 3-29 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

15 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

HO NEY (UNII: Y9 H1V576 FH)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Efficient Laboratories Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 59 3-29 5-0 4

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 1/19 9 7

2

NDC:58 59 3-29 5-0 6

178 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 1/19 9 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 2/0 1/19 9 7

Labeler -

Efficient Laboratories Inc. (969044932)

Registrant -

Efficient Laboratories Inc. (969044932)

Revised: 4/2017