Storage and handling
STORAGEKeep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
STORAGEKeep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg.
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.
Sodium Content: 5 mg/5 mL
Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ.
Hypersensitivity to any of the ingredients
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a physician. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the products used alone. (See WARNINGS
Take orally as stated below or use as directed by a physician. Adults and children 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period; Children 6 to under 12 years: 5 mL (1 teaspoonful) every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period; Children under 6 years: consult a physician. 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 physician could result in serious side effects for a child. Use of codeine-containing preparations is not recommended for children under 2 years of age. Do not exceed recommended dosage.
STORAGEKeep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg.
Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
KEEP OUT OF REACH OF CHILDREN
INDICATIONS
Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
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.
| Class | Version | Type | Effective |
|---|---|---|---|
| CODEINE ANHYDROUS Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 0121-0775-04 | guaifen100,10.jpg | |
| Data code | Code 128 | 0121-5375-07 | guaifen100,10.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-110-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4ebe-f424-e053-dadaa90a57ce | GUAIFENESIN AND CODEINE PHOSPHATE |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-110-04 | GUAIFENESIN AND CODEINE PHOSPHATE | 118 mL in 1 BOTTLE | SOLUTION | 118 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0775-04 | ML - Milliliter | 0121-0775 | ac9f8c15-4f02-4667-b975-5c20f7d93dab | 1 | 2012-07-24 |
| 0121-0775-08 | ML - Milliliter | 0121-0775 | ef3933a2-ccb0-4b44-977e-b6b8f9f14e12 | 1 | 2018-02-20 |
| 0121-0775-16 | ML - Milliliter | 0121-0775 | 270b5b4b-ceb0-4155-ad98-6b3454cf2a29 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Codeine Phosphate | ACTIVE INGREDIENT | GSL05Y1MN6 | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| menthol | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61919-110 | 61919-110-04 |
| 0121-0775 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Guaifenesin | 495W7451VQ | ACTIB |
| Codeine Phosphate | GSL05Y1MN6 | ACTIB |
| edetate disodium | 7FLD91C86K | IACT |
| FD&C Blue No. 1 | H3R47K3TBD | IACT |
| FD&C Red No. 40 | WZB9127XOA | IACT |
| FD&C Yellow No. 6 | H77VEI93A8 | IACT |
| menthol | L7T10EIP3A | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| sodium citrate | 1Q73Q2JULR | IACT |
| sorbitol | 506T60A25R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| menthol | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | PAI Holdings, LLC | 88d0994c-4270-4408-8837-bd97510b2118 | 2024-09-06 | Warnings | 0121-0775 |
| e9a5abb8-ba20-49af-985d-f7156d24562e | 91e9e5e2-5178-4476-9333-02c27bfc4f70 | 2015-10-26 | Warnings | e9a5abb8-ba20-49af-985d-f7156d24562e 91e9e5e2-5178-4476-9333-02c27bfc4f70 |
Adverse event summaries are temporarily unavailable. Other product information remains available.