Indications and uses
pain reliever, cough suppressant and Nasal decongestant
pain reliever, cough suppressant and Nasal decongestant
(in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
pain reliever
Cough Suppressant
Nasal decongestant
pain reliever, cough suppressant and Nasal decongestant
Warnings Failure to follow these warnings could result in serious consequences.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
do not use:
Ask a doctor before use if you have
ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.
Stop use and ask a doctor if:
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide
Call toll free 1-855-314-1850
NDC: 70677-0011-1 24 liquid caps
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 1 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 1 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70677-0011-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1f50-f424-e053-dadaa90a57ce | Acetaminophen, Dextromethorphan and Phenylephrine Day time Cold and Flu |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70677-0011-1 | DayTime Cold and Flu | 24 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 24 | 1 | |
| 70677-0011-1 | DayTime Cold and Flu | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70677-0011 | DAYTIME COLD AND FLU (ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE) CAPSULE, LIQUID FILLED [MCKESSON] | 1 | Legacy NDC, 2 package rows | 20161213_c13ccf97-76eb-4180-bd91-e4d7686f8b15.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70677-0011 | 70677-0011-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| 3fc61a23-87f4-430f-8d08-62e288119c45 | c13ccf97-76eb-4180-bd91-e4d7686f8b15 | 2016-12-12 | Warnings | 3fc61a23-87f4-430f-8d08-62e288119c45 c13ccf97-76eb-4180-bd91-e4d7686f8b15 |
Adverse event summaries are temporarily unavailable. Other product information remains available.