OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask 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.

DOSAGE & ADMINISTRATION SECTION.

Directions. take every hoursdo not exceed doses in 24 hoursa special measuring device should be used to give an accurate dose of this product to children under years of agegiving higher dose than recommended by doctor can result in serious side effects for childadults and children 12 years and over10 mL (2 teaspoonfuls)children to under 12 years of age5 mL (1 teaspoonful)children under years of ageConsult doctor. take every hours. do not exceed doses in 24 hours. special measuring device should be used to give an accurate dose of this product to children under years of age. giving higher dose than recommended by doctor can result in serious side effects for child.

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.

INDICATIONS & USAGE SECTION.

Uses. temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritantshelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive. 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.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredients in each mL (teaspoonful)PurposesCodeine Phosphate, USP 10 mgCough SuppressantGuaifenesin, USP 100 mgExpectorant.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you have. cough with too much phlegm (mucus)a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema. cough with too much phlegm (mucus). persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema.

OTC - DO NOT USE SECTION.

Do not use. in adults and children who have chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by doctor.. in adults and children who have chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under years of age.. Use of codeine-containing preparation is not recommended for children under years of age.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

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

OTC - PURPOSE SECTION.

Active ingredients in each mL (teaspoonful)PurposesCodeine Phosphate, USP 10 mgCough SuppressantGuaifenesin, USP 100 mgExpectorant.

OTC - QUESTIONS SECTION.

Questions or comments. Call 1-800-845-8210 or visit paipharma.comSerious side effects associated with use of this product may be reported to this number.

OTC - STOP USE SECTION.

Stop use and ask doctor if. cough lasts for more than days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of serious condition.may cause or aggravate constipation. cough lasts for more than days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of serious condition.. may cause or aggravate constipation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 473 mL Bottle Label. NDC 0121-0775-16Guaifenesin and Codeine Phosphate Oral Solution USP CV 100 mg/10 mg per mLExpectorant Cough SuppressantAlcohol Free Sugar FreeEach teaspoonful (5 mL) contains: Guaifenesin, USP 100 mg Codeine Phosphate, USP 10 mg Dispense in tight, light-resistant container with child-resistant closure. DO NOT ACCEPT IF SEAL AROUND CAP IS BROKEN OR MISSING 16 fl oz (473 mL)pai Pharmaceutical Associates, Inc. Greenville, SC 29605 Principal Display Panel 473 mL Bottle Label.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other information. Sodium Content: mg/5 mL Tamper evident: Do not use if seal under cap is broken or missingKeep container closed and store away from heatStore at 20- 25C (68-77F). Sodium Content: 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).

WARNINGS SECTION.

Warnings. Do not use. in adults and children who have chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by doctor.. in adults and children who have chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by doctor.. Ask doctor before use if you have. cough with too much phlegm (mucus)a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema. cough with too much phlegm (mucus). persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema. Ask 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 doctor if. cough lasts for more than days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of serious condition.may cause or aggravate constipation. cough lasts for more than days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of serious condition.. may cause or aggravate constipation. If pregnant or breast-feeding, ask health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under years of age.. Use of codeine-containing preparation is not recommended for children under years of age.