Guaifenesin And Codeine Phosphate

Guaifenesin And Codeine Phosphate
SPL v3
SPL
SPL Set ID f5265ae5-db8e-428d-90e9-5eda6a8a22bd
Route
ORAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Codeine Anhydrous (10 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 2023-02-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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 are taking 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)
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.

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
Principal Display Panel 118 Ml Bottle Label

NDC 68788-8361-1

Guaifenesin and Codeine

Phosphate Oral Solution USP

CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:

Guaifenesin, USP 100 mg

Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant

container with a child-resistant closure.

DO NOT ACCEPT IF SEAL

AROUND CAP IS BROKEN OR MISSING

118mL

pai

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Relabeled By: Preferred Pharmaceuticals Inc.


Structured Label Content

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 are taking 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)
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.

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
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

NDC 68788-8361-1

Guaifenesin and Codeine

Phosphate Oral Solution USP

CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:

Guaifenesin, USP 100 mg

Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant

container with a child-resistant closure.

DO NOT ACCEPT IF SEAL

AROUND CAP IS BROKEN OR MISSING

118mL

pai

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Relabeled By: Preferred Pharmaceuticals Inc.


Advanced Ingredient Data


Raw Label Data

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