MIELIM Y MAS- dextromethorphan liquid

Mielim y mas by

Drug Labeling and Warnings

Mielim y mas by is a Otc medication manufactured, distributed, or labeled by Efficient Laboratories Inc., Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: (In each teaspoonful 5 mls)                   Purpose

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

PURPOSE

Cough Suppressant

WARNINGS

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

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

Keep Out of Reach of Children.

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

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

QUESTIONS

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIELIM Y MAS 
dextromethorphan liquid

Product 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
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)