Guaifenesin And Codeine Phosphate

Guaifenesin And Codeine Phosphate
SPL v4
SPL
SPL Set ID a9130f36-4761-4e6b-a383-eca3db06ea93
Route
ORAL
Published
Effective Date 2025-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Sodium Citrate, Unspecified Form Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Menthol, Unspecified Form Propylene Glycol Water Sodium Benzoate Anhydrous Citric Acid Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-27

Description

Drug Facts


Medication Information

Description

Drug Facts

.

Distributed By:

Cardinal Health

Dublin, OH 43017

LC8458470424

Uses
  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Use of codeine-containing preparation is not recommended for children under 2 years of age.
Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Section 53414-9

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

Section 55105-1
Active ingredients in each 5 mL (teaspoonful) Purposes

Codeine Phosphate, USP 10 mg

Cough Suppressant

Guaifenesin, USP 100 mg

Expectorant

Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
  • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • giving a higher dose than recommended by a doctor can result in serious side effects for a child

adults and children 12 years and over

10 mL (2 teaspoonfuls)

children 6 to under 12 years of age

5 mL (1 teaspoonful)

children under 6 years of age

Consult a doctor

Do Not Use
  • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
Other Information
  • Sodium Content:5 mg/5 mL
  • Tamper evident: Do not use if seal under cap is broken or missing
  • Keep container closed and store away from heat
  • Store at 20°- 25°C (68°-77°F)

Overbagged with 5 x 5 mL unit-dose cups in each bag, NDC 55154-5791-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive Ingredients

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions Or Comments?

Call 1-800-845-8210 or visit paipharma.com

Serious side effects associated with use of this product may be reported to this number.

Principal Display Panel

CV

NDC 55154-5791-5

GUAIFENESIN AND CODEINE

PHOSPHATE ORAL SOLUTION USP

100 mg/10 mg per 5 mL

5 CUPS

Stop Use and Ask A Doctor If
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
  • may cause or aggravate constipation
Ask A Doctor Before Use If You Have
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

.

Distributed By:

Cardinal Health

Dublin, OH 43017

LC8458470424

Uses
  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Use of codeine-containing preparation is not recommended for children under 2 years of age.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

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 (teaspoonful) Purposes

Codeine Phosphate, USP 10 mg

Cough Suppressant

Guaifenesin, USP 100 mg

Expectorant

Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
  • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • giving a higher dose than recommended by a doctor can result in serious side effects for a child

adults and children 12 years and over

10 mL (2 teaspoonfuls)

children 6 to under 12 years of age

5 mL (1 teaspoonful)

children under 6 years of age

Consult a doctor

Do Not Use (Do not use)
  • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
Other Information (Other information)
  • Sodium Content:5 mg/5 mL
  • Tamper evident: Do not use if seal under cap is broken or missing
  • Keep container closed and store away from heat
  • Store at 20°- 25°C (68°-77°F)

Overbagged with 5 x 5 mL unit-dose cups in each bag, NDC 55154-5791-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive Ingredients (Inactive ingredients)

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210 or visit paipharma.com

Serious side effects associated with use of this product may be reported to this number.

Principal Display Panel

CV

NDC 55154-5791-5

GUAIFENESIN AND CODEINE

PHOSPHATE ORAL SOLUTION USP

100 mg/10 mg per 5 mL

5 CUPS

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
  • may cause or aggravate constipation
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data


Raw Label Data

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