FDA.reportPublic FDA data

Virtussin AC

Manufacturer
A-S Medication Solutions
Effective date
2021-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:40

Label at a glance#

ProductVirtussin AC
Active ingredientCODEINE PHOSPHATE, GUAIFENESIN
Label structure9 sections

Indications and uses

▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants ▪ your cough to help you sleep ▪ 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 exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Storage and handling

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients
(in each 5 mL = 1 tsp)		Purpose

Codeine phosphate, USP 10 mg

Cough suppressant

Guaifenesin, USP 100 mg

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • your cough to help you sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask your doctor before use if

  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs

OTC - WHEN USING SECTION

When using this product

  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed 6 doses in 24 hours.

Adults and children 12 years
of age and over:

2 tsp (10 mL) every 4 hours,
or as directed by a doctor.

Children 6 to under 12 years
of age:

1 tsp (5 mL) every 4 hours,
or as directed by a doctor.

Children under 6 years
of age:

Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°-30°C (59°-86°F).
You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

Manufactured for: Virtus Pharmaceuticals, LLC
Langhorne, PA 19047
1-888-848-3593
Made in USA

Rev. 07/2019
7270-0016

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5398

NDC: 50090-5398-0 118 mL in a BOTTLE

VIRTUSSIN AC (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN1
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CODEINE ANHYDROUS Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5398-02023-01-30C16284748780-1f386c64a-30b6-0266-e053-dadaa90a7c1aVirtussin AC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5398-0Virtussin AC118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5398VIRTUSSIN AC (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210303_1170ffbd-0cb8-40cd-b55f-2ac800495272.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-252-04ML - Milliliter69543-252b8536b74-70ed-422d-9092-ea1739b225ff12015-10-02
69543-252-16ML - Milliliter69543-25211a1b225-86f3-4aa3-847b-f7c5f169acef12015-10-02

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-539850090-5398-0
69543-252

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
CODEINE PHOSPHATEGSL05Y1MN6ACTIB
GUAIFENESIN495W7451VQACTIB
citric acid monohydrate2968PHW8QPIACT
methylparabenA2I8C7HI9TIACT
potassium citrateEE90ONI6FFIACT
potassium sorbate1VPU26JZZ4IACT
propylparabenZ8IX2SC1OHIACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
sorbitol506T60A25RIACT
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
ef1ab04a-9f62-46cf-9477-b095f521bd7e1170ffbd-0cb8-40cd-b55f-2ac8004952722021-03-02WarningsExact identifier
spl id: ef1ab04a-9f62-46cf-9477-b095f521bd7e
spl set id: 1170ffbd-0cb8-40cd-b55f-2ac800495272

Reported adverse events (FAERS/openFDA)#

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