FDA.reportPublic FDA data

Dr. Simi Children s Cough - Farmacias De Similares TX LLC | Rnv LLC

Manufacturer
Farmacias De Similares TX LLC | Rnv LLC
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:33

Label at a glance#

ProductDr. Simi Children s Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Indications and uses

■ temporarily relieves cough as may occur with the common cold ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

Dosage and administration

■ do not take more than 6 doses in any 24-hour period ■ shake well before use ■ measure only with dosing cup provided ■ keep dosing cup with product ■ mL=milliliter Age Dose children 6 years to under 12 years 5 mL - 10 mL every 4 hours children 4 years to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Purposes

OTC - PURPOSE SECTION

Dextromethorphan HBr 5 mgCough suppressant

Guaifenesin 100 mg

Expectorant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves cough as may occur with the common cold
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

Warnings

WARNINGS SECTION

.

Do not use

OTC - DO NOT USE SECTION

in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

■ persistent or chronic cough such as occurs with asthma
■ cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than 6 doses in any 24-hour period
■ shake well before use
■ measure only with dosing cup provided
■ keep dosing cup with product
■ mL=milliliter

AgeDose
children 6 years to under 12 years

5 mL - 10 mL every 4 hours

children 4 years to under 6 years2.5 mL - 5 mL every 4 hours
children under 4 yearsdo not use

Other information

OTHER SAFETY INFORMATION

■ each 5 mL contains: sodium 3 mg
■ store at room temperature 15-30°C (59-86°F)
■ Do not refrigerate
■ TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

855-280-1079

Principal Display Pane

SPL UNCLASSIFIED SECTION

NDC: 85786-604-04

DR. SIMI

Children’s Cough

Dextromethorphan HBr 5 mg

Cough Suppressant

Guaifenesin 100 mg

Expectorant

Ages 4+ Years

■ Controls cough
■ Relieves chest congestion
■ Breaks up mucus

Free of alcohol, parabens & high fructose corn syrup

4 fl oz (118 mL)

Cherry Flavor

Compare to the active ingredients in Children’s Mucinex® Cough*

*This product is not manufactured or distributed by RB Health (USA), distributor of Children’s Mucinex® Cough.

Distributed by:
FARMACIAS DE SIMILARES TX LLC.
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Carton labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labelingCarton labeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199961000386GTIN-13: 0199961000386
EAN-13: 0199961000386
GTIN-12: 199961000386
UPC-A: 199961000386
GTIN storage (14 digits): 00199961000386		BOX USC0000256 DEXTROME-GUAIF 5MG-5ML-100MG-5MG SOL 4OZ - DR. SIMI USA (Outlined) 0426_pages-to-jpg-0001.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-604-04Dr. Simi Children s Cough118 mL in 1 BOTTLESYRUP1181
85786-604-04Dr. Simi Children s Cough1 in 1 CARTONSYRUP11

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85786-60485786-604-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
FD&C RED NO. 40WZB9127XOAIACT
CITRIC ACID2968PHW8QPIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
GUAIFENESIN495W7451VQACTIB
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Simi Children s CoughDEXTROMETHORPHAN HBR, GUAIFENESINFarmacias De Similares TX LLC5151740a-8270-7bb5-e063-6294a90ae3872026-05-08WarningsExact identifier
ndc (package): 85786-604-04
ndc (product): 85786-604
ndc11 (package): 85786060404
spl id: 5151740a-8271-7bb5-e063-6294a90ae387
spl set id: 5151740a-8270-7bb5-e063-6294a90ae387

Reported adverse events (FAERS/openFDA)#

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