guaifenesin and codeine phosphate oral solution, usp cv

SPL v1

SPL

SPL Set ID f4d616c9-9c2c-7fa7-e053-2a95a90ac5d5

Route

oral

Published

Effective Date 2023-02-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

guaifenesin (100 mg) codeine anhydrous (10 mg)

Inactive Ingredients

anhydrous citric acid glycerin water sodium benzoate saccharin sodium sorbitol

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2022-05-23

Description

Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant

Medication Information

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.

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

Each tsp (5 mL) contains 3 mg sodium.

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.

Inactive Ingredients

Caramel flavor, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

Description

Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant

Principal Display Panel

Section 42229-5

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

Manufactured by:

Quagen Pharmaceuticals LLC

West Caldwell, NJ 07006

MADE IN USA

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 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

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

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.

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

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.

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 (Other information)

Each tsp (5 mL) contains 3 mg sodium.

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.

Inactive Ingredients (Inactive ingredients)

Caramel flavor, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 42229-5 (42229-5)

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

Manufactured by:

Quagen Pharmaceuticals LLC

West Caldwell, NJ 07006

MADE IN USA

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 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

When Using This Product (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

Stop Use and Ask A Doctor If (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.

Ask Your Doctor Before Use If (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

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CODEINE ANHYDROUS", "unii": "UX6OWY2V7J", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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": "Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 MADE IN USA", "50565-1": "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "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.", "Other information": "Each tsp (5 mL) contains 3 mg sodium. Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.", "Inactive ingredients": "Caramel flavor, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.", "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", "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.", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:34.594069 · Updated: 2026-03-14T23:01:03.935839