FDA Label for Guaifenesin And Codeine Phosphate
View Indications, Usage & Precautions
Guaifenesin And Codeine Phosphate Product Label
The following document was submitted to the FDA by the labeler of this product Rpk Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
| Active ingredients in each 5 mL (teaspoonful) | Purposes |
|---|---|
| Codeine Phosphate, USP 10 mg | Cough Suppressant |
| Guaifenesin, USP 100 mg | Expectorant |
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
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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
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.
How Supplied
Product: 53002-3191
NDC: 53002-3191-1 118 mL in a BOTTLE
* Please review the disclaimer below.