Virtussin Ac

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

Medication Information

How Supplied

Product: 50090-5398

NDC: 50090-5398-0 118 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	Cough suppressant
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.

Manufactured for: Virtus Pharmaceuticals, LLC

Langhorne, PA 19047

1-888-848-3593

Made in USA

Rev. 07/2019

7270-0016

Virtussin Ac (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	Cough suppressant
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: 50090-5398

NDC: 50090-5398-0 118 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.

Manufactured for: Virtus Pharmaceuticals, LLC

Langhorne, PA 19047

1-888-848-3593

Made in USA

Rev. 07/2019

7270-0016

Virtussin Ac (codeine Phosphate and Guaifenesin) Liquid (VIRTUSSIN AC (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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.", "42229-5": "Drug Facts", "50565-1": "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "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.", "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", "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Cough suppressant 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": "Product: 50090-5398 NDC: 50090-5398-0 118 mL in a BOTTLE", "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. Manufactured for: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 1-888-848-3593 Made in USA Rev. 07/2019 7270-0016"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information