Guaifenesin And Codeine Phosphate
f5265ae5-db8e-428d-90e9-5eda6a8a22bd
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
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Source: dailymed · Ingested: 2026-02-15T12:06:19.667494 · Updated: 2026-03-14T23:09:03.764166