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NDC 00121-1775-00 Guaifenesin and Codeine Phosphate 10; 100 mg/5mL; mg/5mL Details
Guaifenesin and Codeine Phosphate 10; 100 mg/5mL; mg/5mL
Guaifenesin and Codeine Phosphate is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaceutical Associates, Inc.. 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: 00121-1775-00Last Updated: 11/30/2022
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: 00121-1775-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 00121-1775 |
|---|---|
| Product ID | 0121-1775_e16f3d0c-f07b-3d84-e053-2a95a90a2789 |
| Associated GPIs | 43997002282020 |
| GCN Sequence Number | 070992 |
| GCN Sequence Number Description | codeine phosphate/guaifenesin LIQUID 10-100MG/5 ORAL |
| HIC3 | B4S |
| HIC3 Description | OPIOID ANTITUSSIVE-EXPECTORANT COMBINATION |
| GCN | 34672 |
| HICL Sequence Number | 000206 |
| HICL Sequence Number Description | CODEINE PHOSPHATE/GUAIFENESIN |
| Brand/Generic | Generic |
| Proprietary Name | Guaifenesin and Codeine Phosphate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Codeine Phosphate |
| 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 | Pharmaceutical Associates, Inc. |
| 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 | 2024-12-31 |
Package
Package Images
NDC 00121-1775-00 (00121177500)
| NDC Package Code | 0121-1775-00 |
|---|---|
| Billing NDC | 00121177500 |
| Package | 10 TRAY in 1 CASE (0121-1775-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1775-05) |
| Marketing Start Date | 2006-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 88d0994c-4270-4408-8837-bd97510b2118 Details
SPL UNCLASSIFIED SECTION
Uses
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.
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
Inactive ingredients
Questions or comments?
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 - 5 mL Unit Dose Cup Label
PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label
INGREDIENTS AND APPEARANCE
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| Labeler - Pharmaceutical Associates, Inc. (044940096) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmaceutical Associates, Inc. | 097630693 | manufacture(0121-0775, 0121-1550, 0121-1775) | |