Dr Simi Mucus Relief Expectorant

Manufacturer
Farmacias De Similares TX LLC | Granules India Limited
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:33:52

Label at a glance#

ProductDr Simi Mucus Relief Expectorant
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage and administration

Do not crush, chew, or break tablet. Take with a full glass of water. This product can be administered without regard for timing of meals. Adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. Childrens under 12 years of age: do not use.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each extended-release tablet)

  • Guaifenesin 1200 mg

Purpose

OTC - PURPOSE SECTION

Purpose

  • Expectorant

Uses

INDICATIONS & USAGE SECTION

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

  • For children under 12 years of age.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
  • Cough accompained by too much phlegm (mucus).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Cough lasts more than 7 days, come back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children

Overdosage

OVERDOSAGE SECTION

in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

INDICATIONS & USAGE SECTION

  • Do not crush, chew, or break tablet.
  • Take with a full glass of water.
  • This product can be administered without regard for timing of meals.

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • Childrens under 12 years of age: do not use.

Other information

OTHER SAFETY INFORMATION

  • Store between 20-25°C (68-77°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer homopolymer type B, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION

(855)-280-1079

SPL UNCLASSIFIED SECTION

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

EXP:

PEEL BACK for more DRUG FACTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR SIMI

NDC 85786-301-14

Maximum Strength / Expectorant

Mucus Relief

Guaifenesin 1200 mg

Relieves Chest Congestion

Thins and Loosens Mucus

Immediate and Extended Release

14 Tablets

Extended Release

Bi-Layer Tablets

PDPPDPTDFTDF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN1
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD1
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850072692845GTIN-13: 0850072692845
EAN-13: 0850072692845
GTIN-12: 850072692845
UPC-A: 850072692845
GTIN storage (14 digits): 00850072692845
Principal Display Panel Guaifenesin 1200.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-301-14Dr Simi Mucus Relief Expectorant14 in 1 BOTTLETABLET, EXTENDED RELEASE141

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85786-30185786-301-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 Mucus Relief ExpectorantGUAIFENESINFarmacias De Similares TX LLC3c6d0e75-a685-6020-e063-6294a90a5c1b2025-08-15WarningsExact identifier
ndc (package): 85786-301-14
ndc (product): 85786-301
ndc11 (package): 85786030114
spl id: 3c6d0e75-a686-6020-e063-6294a90a5c1b
spl set id: 3c6d0e75-a685-6020-e063-6294a90a5c1b

Reported adverse events (FAERS/openFDA)#

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