PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label - 1775 Delivers 10 mL NDC 0121-1775-10 G UAIFENESIN AND C ODEINE P HOSPHATE O RAL S OLUTION USP CV 200 mg/20 mg per 10 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free FOR INSTITUTIONAL USE ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT A17751000
OTC - ACTIVE INGREDIENT SECTION.
Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
INDICATIONS & USAGE SECTION.
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
DOSAGE & ADMINISTRATION SECTION.
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
SPL UNCLASSIFIED SECTION.
INACTIVE INGREDIENT SECTION.
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.
STORAGE AND HANDLING SECTION.
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- 25C (68-77F)
OTC - QUESTIONS SECTION.
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.
Warnings 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. 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 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. 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 If pregnant or breast-feeding, ask a health professional before use. 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.