Llorens Care Tussin

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 01:30:14

Label at a glance#

ProductLlorens Care Tussin

Active ingredientGUAIFENESIN

Label structure11 sections

Contacts and useful links#

PhoneLabel contact1-866-595-5598

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each 5 mL teaspoonful

Guaifenesin - 100 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

WARNINGS SECTION

Warnings

Do not use

if you 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 more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,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 right away

DOSAGE & ADMINISTRATION SECTION

Directions

do not take more than 6 doses in a 24 hour period
do not exceed recommended dose


adults and children 12 years and over	2 teaspoonfuls (10 mL) every 4 hours as needed or as directed by a doctor
children under 12 years	do not use

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 1-866-595-5598

RECENT MAJOR CHANGES SECTION

typo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LCTussin510

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-510-16	Llorens Care Tussin	473 mL in 1 BOTTLE	LIQUID	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-510-16	ML - Milliliter	54859-510	3789a6e3-cbb5-41ee-b910-3924463c4d8e	1	2026-01-08

Products#

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

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

Llorens Care Tussin
Guaifenesin
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
MENTHOL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54859-510	54859-510-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
GUAIFENESIN	495W7451VQ	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Llorens Care Tussin	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	474459c1-bfd7-dec7-e063-6394a90ac18d	2025-12-31	Warnings	Exact identifier ndc (package): 54859-510-16 ndc (product): 54859-510 ndc11 (package): 54859051016 spl id: 47445871-7aa8-c908-e063-6394a90a4b97 spl set id: 474459c1-bfd7-dec7-e063-6394a90ac18d

Reported adverse events (FAERS/openFDA)#

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