Virtussin A/c

Virtussin A/c
SPL v2
SPL
SPL Set ID 2ba017d3-1d82-4215-8820-711705540fa4
Route
ORAL
Published
Effective Date 2019-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Methylparaben Potassium Citrate Potassium Sorbate Propylparaben Propylene Glycol Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-07
Description

Drug Facts

How Supplied

Product: 50436-2520 NDC: 50436-2520-1 118 mL in a BOTTLE

Medication Information

How Supplied

Product: 50436-2520

NDC: 50436-2520-1 118 mL in a BOTTLE

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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.
Section 50567-7

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
Section 50569-3

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
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mg Expectorant
Directions
  • 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

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

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

Virtussin A/c (codeine Phosphate and Guaifenesin) Liquid

Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

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
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mg Expectorant
Directions
  • 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.
How Supplied (HOW SUPPLIED)

Product: 50436-2520

NDC: 50436-2520-1 118 mL in a BOTTLE

Other Information (Other information)

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 ingredients)

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

Virtussin A/c (codeine Phosphate and Guaifenesin) Liquid (VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:44.042843 · Updated: 2026-03-14T22:55:23.037919