Indications and uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• do not exceed 6 doses in a 24-hour period • this adult product is not intended for use in children under 12 years of age adults and children 12 years and over 2 teaspoonfuls (tsps) every 4 hours children under 12 years do not use Age Dose
Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg
Dextromethorphan HBr...................Cough suppressant Guaifenesin, USP..............................Expectorant
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• do not use more than directed
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
• do not exceed 6 doses in a 24-hour period • this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over 2 teaspoonfuls (tsps) every 4 hours children under 12 years do not use
Age
Dose
• store at controlled room temperature
alcohol-free
acesulfame potassium, citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 2 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 2 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-5180-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8566-f424-e053-dadaa90a57ce | Drug Facts |
| 17856-5180-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8566-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-5180-1 | Tussin Sugar Free Cough | 10 mL in 1 CUP | LIQUID | 10 | 2 | |
| 17856-5180-2 | Tussin Sugar Free Cough | 5 mL in 1 CUP | LIQUID | 5 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-5180 | TUSSIN SUGAR FREE COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 2 | Legacy NDC, 2 package rows | 20120511_c1288446-789a-447c-b9ef-61d4a5427b9d.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-5180-1 | ML - Milliliter | 17856-5180 | a0124166-83cb-4009-bb76-5f6399704e62 | 1 | 2015-10-02 |
| 0904-5180-09 | ML - Milliliter | 0904-5180 | 5e5e5d69-7778-4b6e-b7df-30ccd1109cbd | 1 | 2012-07-24 |
| 0904-5180-20 | ML - Milliliter | 0904-5180 | 0cfd44e1-25ed-494d-8769-7beee1036daa | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 2 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 2 | |
| acesulfame potassium | INACTIVE INGREDIENT | 23OV73Q5G9 | 2 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| saccharin sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 2 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17856-5180 | 17856-5180-1, 17856-5180-2 |
| 0904-5180 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| acesulfame potassium | 23OV73Q5G9 | IACT |
| citric acid monohydrate | 2968PHW8QP | IACT |
| glycerin | PDC6A3C0OX | IACT |
| methylparaben | A2I8C7HI9T | IACT |
| polyethylene glycol | 3WJQ0SDW1A | IACT |
| povidone | FZ989GH94E | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| saccharin sodium | SB8ZUX40TY | IACT |
| sodium benzoate | OJ245FE5EU | 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 |
|---|---|---|---|---|---|---|
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, CHEWABLE / ORAL | 84 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET / ORAL | 111 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | NA | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, COATED / ORAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / AURICULAR (OTIC) | 0.2 %w/v | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| povidone | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INHALANT / RESPIRATORY (INHALATION) | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / TOPICAL | 0.2 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| povidone | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | FILM, SOLUBLE / ORAL | 10 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | LOZENGE / ORAL | 120 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w |
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 |
|---|---|---|---|---|---|---|
| 12eab105-e605-4010-8be9-850f593ac064 | c1288446-789a-447c-b9ef-61d4a5427b9d | 2009-11-14 | Warnings | 12eab105-e605-4010-8be9-850f593ac064 c1288446-789a-447c-b9ef-61d4a5427b9d |
Adverse event summaries are temporarily unavailable. Other product information remains available.