Search by Drug Name or NDC
NDC 72189-0337-04 CODEINE-GUAIFENESIN 10; 100 mg/5mL; mg/5mL Details
CODEINE-GUAIFENESIN 10; 100 mg/5mL; mg/5mL
CODEINE-GUAIFENESIN is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Direct Rx. The primary component is CODEINE PHOSPHATE; GUAIFENESIN.
MedlinePlus Drug Summary
Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
Related Packages: 72189-0337-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Codeine
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 72189-0337-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 72189-0337 |
|---|---|
| Product ID | 72189-337_d9a75569-10bd-451d-e053-2995a90a5b37 |
| Associated GPIs | 43997002282020 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | CODEINE-GUAIFENESIN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | codeine phosphate and guaifenesin solution |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | CODEINE PHOSPHATE; GUAIFENESIN |
| Labeler Name | Direct Rx |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC] |
| DEA Schedule | CV |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 72189-0337-04 (72189033704)
| NDC Package Code | 72189-337-04 |
|---|---|
| Billing NDC | 72189033704 |
| Package | 118 mL in 1 BOTTLE (72189-337-04) |
| Marketing Start Date | 2022-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d9a75569-10bc-451d-e053-2995a90a5b37 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Ask your doctor before use if
you have a persistent cough, this may be a sign of a serious condition
you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
you have a cough that is accompanied by excessive phlegm (mucus)
you have chronic pulmonary disease or shortness of breath
giving to a child who is taking other drugs
When using this product
giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
may cause or aggravate constipation
Stop use and ask a doctor if
symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| CODEINE-GUAIFENESIN
codeine phosphate and guaifenesin solution solution |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Direct Rx (079254320) |
| Registrant - Direct Rx (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Direct Rx | 079254320 | repack(72189-337) | |