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
take only as recommended-see Overdose warning Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours ---------------------------------------------------------------------------------------------------------------------- adults and children 12 years and over 30 mL (2 TBSP) every 6 hours ____________________________________________________________________ children 4 to under 12 years ...
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
These could be signs of a serious condition.
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.
----------------------------------------------------------------------------------------------------------------------
adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
____________________________________________________________________
children 4 to under 12 years ask a doctor
____________________________________________________________________
children under 4 years do not use
____________________________________________________________________
Inactive ingredients
:citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
Do not use
NDC 76281-502-28
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
Cherry Flavor
12 FL OZ (354 mL)
DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
Questions?Call weekdays 1-877-798-5944
*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
4 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 | 11 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 11 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 11 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 11 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 11 |
| 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 | 0376281502251 | GTIN-13: 0376281502251 EAN-13: 0376281502251 GTIN-12: 376281502251 UPC-A: 376281502251 GTIN storage (14 digits): 00376281502251 | 502 6oz label.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-502-24 | Nite-TimeCOLD/FLU Medicine Cherry | 118 mL in 1 BOTTLE | LIQUID | 118 | 11 | |
| 76281-502-25 | Nite-TimeCOLD/FLU Medicine Cherry | 177 mL in 1 BOTTLE | LIQUID | 177 | 11 | |
| 76281-502-28 | Nite-TimeCOLD/FLU Medicine Cherry | 354 mL in 1 BOTTLE | LIQUID | 354 | 11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76281-502 | 76281-502-28, 76281-502-25, 76281-502-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 10 | 2025-11-07 | monthly-update | 2026-06-03 17:38:33 |
| 9 | 2023-12-11 | full-release | 2026-06-01 00:03:54 |
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 Cherry | ACETAMINOPHEN | AptaPharma Inc. | 87c2b823-ed88-44f3-8f6a-df30430b40f3 | 2025-12-26 | Warnings | 76281-502-25 76281-502-28 76281-502-24 76281-502 76281050225 76281050228 76281050224 46e2d507-7545-48c8-e063-6294a90a6c67 87c2b823-ed88-44f3-8f6a-df30430b40f3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.