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
Guaifenesin And Codeine Phosphate Solution
FDA Label NDC 0121-1775
11 label sections · Submitted to the FDA by Pai Holdings, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc for the product Guaifenesin And Codeine Phosphate (NDC 0121-1775). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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 |
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.
Principal Display Panel - 473 Ml Bottle Label
NDC 0121-0775-16
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
16 fl oz (473 mL)
pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
Principal Display Panel (473 mL Bottle Label)
Principal Display Panel - 5 Ml Unit Dose Cup Label
Delivers 5 mL
NDC 0121-1775-05
G UAIFENESINAND C ODEINEP HOSPHATE
O RALS OLUTIONUSP CV
100 mg/10 mg per 5 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar Free
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
Principal Display Panel (10 mL Unit Dose Cup Label)
Principal Display Panel - 10 Ml Unit Dose Cup Label
Delivers 10 mL
NDC 0121-1550-10
G UAIFENESINAND C ODEINEP HOSPHATE
O RALS OLUTIONUSP CV
200 mg/20 mg per 10 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar Free
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
Principal Display Panel (10 mL Unit Dose Cup Label)
* Please review the disclaimer below.
