Indications and uses
temporarily relieves cold symptoms: • cough due to minor throat and bronchial irritation • runny nose and sneezing
temporarily relieves cold symptoms: • cough due to minor throat and bronchial irritation • runny nose and sneezing
• take only as directed • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
• each 30 mL contains: sodium 32 mg • store at 20-25 ° C (68-77 ° F)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Cough suppressant
Antihistamine
temporarily relieves cold symptoms:
taking sedatives or tranquilizers
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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).
adults & children 12 yrs & over | 30 mL every 6 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
1-855-423-2630
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41163-551-40 | ML - Milliliter | 41163-551 | 3907b85d-fffe-468e-b588-39269f0a3cad | 1 | 2016-10-06 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 41163-551 | 41163-551-40 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / ORAL | 3900 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / TOPICAL | 4.35 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE / ORAL | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / PERINEURAL | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %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 |
|---|---|---|---|---|---|---|
| 44bb934d-61b0-43e9-8f48-335f32ee25ee | 17af0b3d-61e4-4c1a-be6d-100c10f28d17 | 2024-10-22 | Warnings | 44bb934d-61b0-43e9-8f48-335f32ee25ee 17af0b3d-61e4-4c1a-be6d-100c10f28d17 |
Adverse event summaries are temporarily unavailable. Other product information remains available.