Mielim y mas

Manufacturer: Efficient Laboratories Inc.
Effective date: 2024-10-14
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:25:17

Label at a glance#

ProductMielim y mas

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE

Label structure11 sections

Contacts and useful links#

PhoneLabel contact305.805.3456

Websitewww.efficientlabs.com

www.efficientlabs.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: (In each teaspoonful 5 mls) Purpose

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

OTC - PURPOSE SECTION

Cough Suppressant

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mielim

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1099285	dextromethorphan hydrobromide 3 MG/ML Oral Solution [Mielim Y Mas]	dextromethorphan hydrobromide 3 MG/ML Oral Solution [Mielim Y Mas]	SBD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1090496	dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	8
1099285	Mielim y mas 15 MG in 5 mL Oral Solution	PSN	8
1099285	dextromethorphan hydrobromide 3 MG/ML Oral Solution [Mielim Y Mas]	SBD	8
1090496	dextromethorphan hydrobromide 3 MG/ML Oral Solution	SCD	8
1090496	dextromethorphan hydrobromide 15 MG per 5 ML Oral Solution	SY	8
1090496	dextromethorphan hydrobromide 30 MG per 10 ML Oral Solution	SY	8
1099285	Mielim Y Mas 15 MG per 5 ML Oral Solution	SY	8
1099285	Mielim Y Mas 3 MG/ML Oral Solution	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58593-295-04	2020-02-18	C162847	48780-1	9d75b9cf-d38e-f424-e053-dadaa90a57ce	Drug Facts
58593-295-06	2020-02-18	C162847	48780-1	9d75b9cf-d38e-f424-e053-dadaa90a57ce	Drug Facts
58593-295-04	2020-01-31	C162847	48780-1	9d75b9cf-d38e-f424-e053-dadaa90a57ce	Drug Facts
58593-295-06	2020-01-31	C162847	48780-1	9d75b9cf-d38e-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-295-04	Mielim y mas	118 mL in 1 BOTTLE	LIQUID	118		8
58593-295-06	Mielim y mas	178 mL in 1 BOTTLE	LIQUID	178		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-295	MIELIM Y MAS (DEXTROMETHORPHAN) LIQUID [EFFICIENT LABORATORIES INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241016_711d1dae-3af4-46af-a3a8-cd827356a81a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Mielim y mas
Dextromethorphan
ASPARTAME
HONEY
POTASSIUM SORBATE
PROPYLENE GLYCOL
PROPYLPARABEN
METHYLPARABEN
WATER
SODIUM CHLORIDE
DEXTROMETHORPHAN HYDROBROMIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58593-295	58593-295-04, 58593-295-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPARTAME	Z0H242BBR1	IACT
HONEY	Y9H1V576FH	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SYRUP / ORAL	0.63 mg/5ml		Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	GRANULE, EFFERVESCENT / ORAL	30 mg		Exact identifier — unii+route 51 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, FILM COATED / ORAL		20 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii+route 60 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	LOZENGE / ORAL		136 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SYRUP / ORAL	0.63 mg/5ml		Exact identifier — unii+route 51 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SOLUTION / ORAL	233 mg		Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SOLUTION / ORAL		40 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER / ORAL		63 mg	Exact identifier — unii+route 51 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii+dosage form 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii+dosage form 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	GRANULE, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SOLUTION / ORAL		40 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER / ORAL		63 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii+route 51 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL		87 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 51 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii+route 60 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii+route 60 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SYRUP / ORAL	0.63 mg/5ml		Exact identifier — unii+route 51 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL		87 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	LOZENGE / ORAL		136 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, FILM COATED / ORAL		20 mg	Exact identifier — unii+route 51 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii+route 60 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii+route 60 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii+route 60 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii+route 51 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mielim y mas	DEXTROMETHORPHAN	Efficient Laboratories Inc.	711d1dae-3af4-46af-a3a8-cd827356a81a	2024-10-14	Warnings	Exact identifier ndc (package): 58593-295-06 ndc (package): 58593-295-04 ndc (product): 58593-295 ndc11 (package): 58593029506 ndc11 (package): 58593029504 spl id: 24701771-2c31-2dfd-e063-6394a90a99db spl set id: 711d1dae-3af4-46af-a3a8-cd827356a81a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.