FDA.reportPublic FDA data

Tussin

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:57

Label at a glance#

ProductTussin
Active ingredientGUAIFENESIN
Label structure9 sections

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 – 20 mL every 4 hours children under 12 years do not use

Storage and handling

store at 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

10 – 20 mL every 4 hours

children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN1
310604guaifenesin 20 MG/ML Oral SolutionSCD1
310604guaifenesin 100 MG per 5 ML Oral SolutionSY1
310604guaifenesin 100 MG per 5 ML Oral SyrupSY1
310604guaifenesin 200 MG per 10 ML Oral SolutionSY1
310604guaifenesin 300 MG per 15 ML Oral SolutionSY1
310604guaifenesin 400 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2663-42025-01-30C16284748780-12cef2736-8746-d83d-e063-dadaa90ab31fMcKesson Adult Tussin Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2663-4Tussin118 mL in 1 BOTTLESOLUTION1181
68071-2663-4Tussin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2663TUSSIN (GUAIFENESIN) SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220329_db4a5925-e864-42ba-e053-2a95a90ad381.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-135-34ML - Milliliter49348-1351918039d-31fd-4565-a59d-248561298c0e12015-05-05
49348-135-37ML - Milliliter49348-135fb803d6b-5607-4743-8d0c-ad1777ddaeba12015-10-02

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-266368071-2663-4
49348-135

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARAMELT9D99G2B1RIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
GUAIFENESIN495W7451VQACTIB

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
db4a5925-e865-42ba-e053-2a95a90ad381db4a5925-e864-42ba-e053-2a95a90ad3812022-03-28WarningsExact identifier
spl id: db4a5925-e865-42ba-e053-2a95a90ad381
spl set id: db4a5925-e864-42ba-e053-2a95a90ad381

Reported adverse events (FAERS/openFDA)#

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