Indications and uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation
• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use
• each 10 mL contains: sodium 5 mg • store at 20-25ºC (68-77ºF). Do not refrigerate.
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Phenylephrine HCl, USP 10 mg
Cough suppressant
Expectorant
Nasal decongestant
do not use more than directed
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
age | dose |
adults and children 12 years and over | 10 mL every 4 hours |
children under 12 years | do not use |
anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 56062-516-26 | ML - Milliliter | 56062-516 | a4203aac-8447-41f2-a594-4f6116fce9dd | 1 | 2012-07-24 |
| 56062-516-34 | ML - Milliliter | 56062-516 | c6998593-f314-4747-a168-7ee26fa66d9e | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 3 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 3 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 3 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 3 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 3 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 3 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 56062-516 | 56062-516-26, 56062-516-34 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / SUBLINGUAL | 36 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY, METERED / NASAL | 1.2 mg/1ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE / ORAL | 131 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / IONTOPHORESIS | 0.1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / SUBCUTANEOUS | 101 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAVENOUS | 772 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / ORAL | 197 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v |
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 |
|---|---|---|---|---|---|---|
| a196b057-a79b-400d-a114-9d2f8eeb8b22 | 475af5dc-ec6a-44e7-978d-28b49214ce66 | 2024-10-18 | Warnings | a196b057-a79b-400d-a114-9d2f8eeb8b22 475af5dc-ec6a-44e7-978d-28b49214ce66 |
Adverse event summaries are temporarily unavailable. Other product information remains available.