FDA.reportPublic FDA data

Tussin Mucus and Chest Congestion Sugar Free

Manufacturer
AARNA USA, Inc.
Effective date
2023-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:11

Label at a glance#

ProductTussin Mucus and Chest Congestion Sugar Free
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in any 24-hour period 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

Each 10 mL contains: Sodium 3.2 mg store between 20º-25ºC(68º-77ºF). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 200 mg 

Purposes

OTC - PURPOSE SECTION

Expectorant

Purposes

OTC - PURPOSE SECTION

Expectorant

Uses

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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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
  • 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

  • Each 10 mL contains: Sodium 3.2 mg
  • store between 20º-25ºC(68º-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, cherry flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

toll-free 1-877-225-6999

Manufactured for:

AARNA USA Inc.

Leland NC, 28451

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4-lbl4-lbl

4-crt4-crt

8-lbl8-lbl

8-crt8-crt

16-lbl16-lbl

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82568-0012-4Tussin Mucus and Chest Congestion Sugar Free118 mL in 1 BOTTLE, PLASTICLIQUID1181
82568-0012-4Tussin Mucus and Chest Congestion Sugar Free1 in 1 PACKAGELIQUID11
82568-0012-6Tussin Mucus and Chest Congestion Sugar Free473 mL in 1 BOTTLE, PLASTICLIQUID4731
82568-0012-8Tussin Mucus and Chest Congestion Sugar Free1 in 1 PACKAGELIQUID11
82568-0012-8Tussin Mucus and Chest Congestion Sugar Free236 mL in 1 BOTTLE, PLASTICLIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0012TUSSIN MUCUS AND CHEST CONGESTION SUGAR FREE (GUAIFENESIN) LIQUID [AARNA USA, INC.]1Current NDC, 5 package rows20250228_6e488782-0138-436d-a9f0-0ec5bc9daedd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0012-4ML - Milliliter82568-0012a393c961-6b94-44a4-afa4-8e120468d24d12025-05-14
82568-0012-6ML - Milliliter82568-001239537577-7cd3-44a1-b4e2-98347b606fa912025-05-14
82568-0012-8ML - Milliliter82568-001214c90c97-9f31-4c2a-acbf-201a5418d79f12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82568-001282568-0012-4, 82568-0012-8, 82568-0012-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
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
Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAARNA USA, Inc.6e488782-0138-436d-a9f0-0ec5bc9daedd2023-05-15WarningsExact identifier
ndc (package): 82568-0012-4
ndc (package): 82568-0012-6
ndc (package): 82568-0012-8
ndc (product): 82568-0012
ndc11 (package): 82568001206
ndc11 (package): 82568001204
ndc11 (package): 82568001208
spl id: 86b38bae-a0d7-48cd-a7ba-ceb5e2a719cf
spl set id: 6e488782-0138-436d-a9f0-0ec5bc9daedd

Reported adverse events (FAERS/openFDA)#

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