Guaifenesin and Codeine Phosphate 10 mg/5mL
Guaifenesin and Codeine Phosphate · SOLUTION · PAI Holdings, LLC
Guaifenesin and Codeine Phosphate is a solution containing guaifenesin and codeine phosphate at 10 mg/5mL, taken oral. Manufactured by PAI Holdings, LLC.
Key Facts
- Brand Name
- Guaifenesin and Codeine Phosphate
- Generic Name
- Guaifenesin and Codeine Phosphate
- NDC Code (Product)
0121-1775- Manufacturer
- PAI Holdings, LLC
- Strength
- 10 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- M012
- Drug Class
- Expectorant [EPC]
- Marketing Start
- 10/01/2006
Recall History
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Superpotent; sodium benzoate preservative
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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
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
Warnings
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.
Frequently Asked Questions
What is Guaifenesin and Codeine Phosphate used for?
Guaifenesin and Codeine Phosphate contains Guaifenesin and Codeine Phosphate. It is a solution taken oral. Consult your doctor for specific uses.
Is Guaifenesin and Codeine Phosphate a controlled substance?
Yes, Guaifenesin and Codeine Phosphate is classified as CV under the DEA Controlled Substances Act.
What is the generic name for Guaifenesin and Codeine Phosphate?
The generic name for Guaifenesin and Codeine Phosphate is Guaifenesin and Codeine Phosphate. There are no other listed brand versions of Guaifenesin and Codeine Phosphate.
What is the NDC code for Guaifenesin and Codeine Phosphate 10 mg/5mL?
The NDC (National Drug Code) for Guaifenesin and Codeine Phosphate 10 mg/5mL is 0121-1775, listed by PAI Holdings, LLC.
Other Guaifenesin and Codeine Phosphate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)