Indications and uses
Uses temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever
Uses temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever
Directions take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL (2TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use If taking Nite Time at night and Day Time during th...
Drug Facts
Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine
Keep out of reach of children.
Uses temporarily relieves cold/flu symptoms:
Liver warning:This product contains acetaminophen. Severe liver damage
may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is
the maximum daily amount for this product ● with other drugs containing
acetaminophen ● 3 or more alcoholic drinks everyday while using this product.
Sore throat warning:If sore throat is severe, persists for more than 2 days,
is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
adults and children 12 years and over 30 mL (2TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
Other information
Inactive ingredients: citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
Do not use
NDC 76281-501-28
AP SAFE
*COMPARE TO
the active ingredients in
VICKS
®NYQUIL
®
Night Time
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine Succinate – Antihistamine
Multi-Symptom
Cold & Flu Relief
Original Flavor
12 FL OZ (354 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® NyQuil®.
Manufactured by: AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 08110
12 OZ
6 OZ
res
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 9 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 9 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 9 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 9 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 9 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0376281501285 | GTIN-13: 0376281501285 EAN-13: 0376281501285 GTIN-12: 376281501285 UPC-A: 376281501285 GTIN storage (14 digits): 00376281501285 | 501-28 12oz Botl.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-501-25 | Nite-TimeCOLD/FLU Medicine | 177 mL in 1 BOTTLE | LIQUID | 177 | 9 | |
| 76281-501-28 | Nite-TimeCOLD/FLU Medicine | 354 mL in 1 BOTTLE | LIQUID | 354 | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76281-501 | 76281-501-28, 76281-501-25 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Nite-Time COLD/FLU Medicine | ACETAMINOPHEN | AptaPharma Inc. | 344440bc-d810-4296-93ec-e6ae6673856b | 2025-12-26 | Warnings | 76281-501-28 76281-501-25 76281-501 76281050125 76281050128 46e2c8b6-bd83-7100-e063-6294a90ac998 344440bc-d810-4296-93ec-e6ae6673856b |
Adverse event summaries are temporarily unavailable. Other product information remains available.