Indications and uses
temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and 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 and pains fever runny nose and sneezing
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Pain reliever/Fever reducer
Cough suppressant
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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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
These could be signs of a serious condition.
If pregnant or breast-feeding,ask a health professional before use.
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 & children 12 yrs & over | 2 softgels with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
D&C yellow# 10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution
1-844-832-1138
M-F 9am-5pm EST
Health Pharma USA LLC
Rahway, NJ 07065
www.health-Pharma.us
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71679-102-00 | Nighttime Cold and Flu | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 5 | |
| 71679-102-00 | Nighttime Cold and Flu | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 71679-102-50 | Nighttime Cold and Flu | 50 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 50 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71679-102 | NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [HEALTH PHARMA USA LLC] | 5 | Current NDC, 3 package rows | 20250109_29bb7822-76c6-e39d-e063-6294a90a64fb.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71679-102 | 71679-102-50, 71679-102-00 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Nighttime Cold and Flu | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | Health Pharma USA LLC | 29bb7822-76c6-e39d-e063-6294a90a64fb | 2025-01-07 | Warnings | 71679-102-50 71679-102-00 71679-102 71679010200 71679010250 2b2207d5-7fd6-5737-e063-6394a90acc00 29bb7822-76c6-e39d-e063-6294a90a64fb |
Adverse event summaries are temporarily unavailable. Other product information remains available.