Indications and uses
temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches/pains fever runny nose and sneezing
temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches/pains fever runny nose and sneezing
Take only as recommended—see Overdose warning . do not exceed 4 doses per 24 hours adults and children 12 years of age and over swallow 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine
Drug Facts
| Active ingredients (in each softgel) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan Hydrobromide 15 mg | Cough suppressant |
| Doxylamine Succinate 6.25 mg | Antihistamine |
temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
| adults and children 12 years of age and over | swallow 2 softgels with water every 6 hours |
| children 4 to under 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
1-888-333-9792
Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
VALUMEDS™
SEE NEW WARNINGS INFORMATION
Compare to the active ingredients
in VICKS® NyQUIL®*
MULTI-SYMPTOM
NITE TIME
COLD&FLU NIGHTTIME RELIEF
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE
48 SOFTGELS
Liquid filled capsules
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 7 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 7 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 7 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68210-1050-0 | 2026-01-29 | C162847 | 48780-1 | 49896155-b768-586f-e063-e6dba90add90 | VALUMEDS MULTI-SYMPTOM NITE TIME COLD&FLU CAPSULES |
| 68210-1050-1 | 2026-01-29 | C162847 | 48780-1 | 49896155-b768-586f-e063-e6dba90add90 | VALUMEDS MULTI-SYMPTOM NITE TIME COLD&FLU CAPSULES |
| 68210-1050-2 | 2026-01-29 | C162847 | 48780-1 | 49896155-b768-586f-e063-e6dba90add90 | VALUMEDS MULTI-SYMPTOM NITE TIME COLD&FLU CAPSULES |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-1050-0 | MULTI-SYMPTOM NITETIME | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 7 | |
| 68210-1050-0 | MULTI-SYMPTOM NITETIME | 48 in 1 CARTON | CAPSULE, LIQUID FILLED | 48 | 7 | |
| 68210-1050-1 | MULTI-SYMPTOM NITETIME | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 7 | |
| 68210-1050-1 | MULTI-SYMPTOM NITETIME | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 7 | |
| 68210-1050-2 | MULTI-SYMPTOM NITETIME | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 7 | |
| 68210-1050-2 | MULTI-SYMPTOM NITETIME | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 7 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-1050 | MULTI-SYMPTOM NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC] | 7 | Legacy NDC, 6 package rows | 20241215_a98404a8-5b74-4d4d-9f2a-42677e9ff585.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68210-1050 | 68210-1050-0, 68210-1050-1, 68210-1050-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
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 |
|---|---|---|---|---|---|---|
| 292c10d0-9aff-cbea-e063-6294a90aa1fd | a98404a8-5b74-4d4d-9f2a-42677e9ff585 | 2024-12-13 | Warnings | 292c10d0-9aff-cbea-e063-6294a90aa1fd a98404a8-5b74-4d4d-9f2a-42677e9ff585 |
Adverse event summaries are temporarily unavailable. Other product information remains available.