Llorens Care Tussin DM

Manufacturer
Llorens Pharmaceutical International Division, Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:13

Label at a glance#

ProductLlorens Care Tussin DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each 5 mL

Dextromethorphan - 10 mg

Guaifenesin - 100 mg

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

WARNINGS SECTION

Warnings

Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.

Do not useif you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or head that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
Age Dose
Adults and children over 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
Children under 12 years ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients artificial and natural cherry flavor, citric acid, FD&C #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

OTC - QUESTIONS SECTION

Questions or comments? 1-866-595-5598

RECENT MAJOR CHANGES SECTION

fix typos

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LCTussinDM833LCTussinDM833

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
54859-833-04Llorens Care Tussin DM118 mL in 1 BOTTLELIQUID1181

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
54859-83354859-833-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Llorens Care Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.4743e562-1217-50ab-e063-6394a90af88d2025-12-31WarningsExact identifier
ndc (package): 54859-833-04
ndc (product): 54859-833
ndc11 (package): 54859083304
spl id: 4743ed64-7bc4-9a11-e063-6294a90a76d1
spl set id: 4743e562-1217-50ab-e063-6394a90af88d

Reported adverse events (FAERS/openFDA)#

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