Uses
Uses
temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches/pains fever
Non-Drowsy DAYTIME COLD & FLU MULTI-SYMPTOM
- Set ID
- 056c826c-5797-479c-8a4f-d05f31641a1b
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:40
Key Label Information
Warnings
Warnings
Directions And Dosage
Directions
■ do not take more than the recommended dose ■ adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor. ■ children under 12 years: do not use
Other Label Information
Other information
store at room temperature. Avoid excessive heat above 40°c (104°F).
Inactive ingredients
FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, lecithin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Multi-symptom Non-drowsy Daytime Cold & Flu Acetaminophen - Pain Reliever / Fever Reducer Dextromethorphan HBr - Cough Suppressant Phenylephrine HCl - Nasal Decongestant Relief of: • Headache • Body Ache • Sore Throat • Nasal Congestion • Sinus Pressure • Cough 10 Softgels
Products
- MULTI-SYMPTOM DAYTIME
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Uses
temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches/pains fever
Warnings
Directions
■ do not take more than the recommended dose ■ adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor. ■ children under 12 years: do not use
Other information
store at room temperature. Avoid excessive heat above 40°c (104°F).
Inactive ingredients
FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, lecithin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Multi-symptom Non-drowsy Daytime Cold & Flu Acetaminophen - Pain Reliever / Fever Reducer Dextromethorphan HBr - Cough Suppressant Phenylephrine HCl - Nasal Decongestant Relief of: • Headache • Body Ache • Sore Throat • Nasal Congestion • Sinus Pressure • Cough 10 Softgels
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/056c826c-5797-479c-8a4f-d05f31641a1b/292c302c-89e2-7e22-e063-6394a90ad940.xml
- XML SHA-256
- 14c4d2d4369e9e70d026fd5c158fa1dfc2e03cf237e2da390038bceeaa17c81e
- XML bytes
- 32582
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 292c302c-89e2-7e22-e063-6394a90ad940.xml | 2024-12-15 |
| otc | 0c023eb3-c0f0-0c95-e063-6294a90ab934.xml | 2023-12-09 |
| otc | ef57f9dc-79ca-7f73-e053-2a95a90a531e.xml | 2022-12-11 |
| otc | ValuHealth DayTime ColdFlu.jpg | 2022-12-11 |