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
1-800-719-9260
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0113-0668-30 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-6db5-198a-e063-dbdaa90aec3e | Perrigo Night Time Cough Drug Facts |
| 0113-0668-34 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-6db5-198a-e063-dbdaa90aec3e | Perrigo Night Time Cough Drug Facts |
| 0113-0668-40 | 2023-08-03 | C162847 | 48780-1 | 0191ceaa-6db5-198a-e063-dbdaa90aec3e | Perrigo Night Time Cough Drug Facts |
| 0113-0668-30 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6db5-198a-e063-dbdaa90aec3e | Perrigo Night Time Cough Drug Facts |
| 0113-0668-34 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6db5-198a-e063-dbdaa90aec3e | Perrigo Night Time Cough Drug Facts |
| 0113-0668-40 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6db5-198a-e063-dbdaa90aec3e | Perrigo Night Time Cough Drug Facts |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0668-30 | ML - Milliliter | 0113-0668 | b05afa09-93e7-4093-b3d7-46f6b6909580 | 1 | 2012-07-24 |
| 0113-0668-34 | ML - Milliliter | 0113-0668 | 303409c1-2a3f-454f-80f8-4b3ce374f05c | 1 | 2018-02-20 |
| 0113-0668-40 | ML - Milliliter | 0113-0668 | d1a131b5-9dd7-4690-a9a2-94b2ddccf3cd | 1 | 2024-02-14 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 4 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 4 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 4 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 4 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 4 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0113-0668 | 0113-0668-30, 0113-0668-34, 0113-0668-40 |
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 |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / ORAL | 46 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / ORAL | 15 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 414 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / RESPIRATORY (INHALATION) | 5 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / PERINEURAL | 0.02 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 81 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE, LIQUID FILLED / ORAL | 360 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAMUSCULAR | 25 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LOZENGE / TRANSMUCOSAL | 44 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE / ORAL | 131 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION, EXTENDED RELEASE / ORAL | 62 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION/ DROPS / AURICULAR (OTIC) | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | ELIXIR / ORAL | 15 mg/5ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| 5ba12346-3813-4ef3-9cc7-fa2d78329f71 | f7d380ba-66bf-43cc-8b08-070bfe20af80 | 2024-10-22 | Warnings | 5ba12346-3813-4ef3-9cc7-fa2d78329f71 f7d380ba-66bf-43cc-8b08-070bfe20af80 |
Adverse event summaries are temporarily unavailable. Other product information remains available.