Virtussin A/C

Manufacturer
Proficient Rx LP
Effective date
2019-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:56:43

Label at a glance#

ProductVirtussin A/C
Active ingredientCodeine phosphate, Guaifenesin
Label structure8 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

Antitussive

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.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 71205-363-04

Virtussin
A/C

Antitussive
Expectorant

CV

ALCOHOL-FREE / SUGAR-FREE

Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP    10 mg
Guaifenesin, USP    100 mg
(WARNING: May be habit-forming)

Tamper evident by foil
seal under cap.
Do not use if foil seal is
broken or missing.

16 fl. oz. (473 mL)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

71205-363-04
71205-363-04

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-363-04ML - Milliliter71205-363bc1ed355-1a38-483b-8327-a51b324503b712020-01-03
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
71205-36371205-363-04
69543-252

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
f21ebdf8-5dc4-44bd-9889-3f71ad6c8f8ad9a7c7eb-22e1-4361-a708-99f4ed5c3a2c2024-10-01WarningsExact identifier
spl set id: d9a7c7eb-22e1-4361-a708-99f4ed5c3a2c

Reported adverse events (FAERS/openFDA)#

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