Indications and uses
temporarily relieves common cold and flu symptoms: ■ minor aches & pains ■ headache ■ sore throat ■ nasal congestion ■ fever ■ cough due to minor throat & bronchial irritation
temporarily relieves common cold and flu symptoms: ■ minor aches & pains ■ headache ■ sore throat ■ nasal congestion ■ fever ■ cough due to minor throat & bronchial irritation
■ take only as directed- see OVERDOSE WARNING ■ do not exceed 8 softgels per 24 hrs. Adults and children age 12 yrs and over take 2 softgels with water every 4 hrs. Children 4 to under 12 yrs ask a doctor Children under 4 yrs do not use
■ store at room temperature between 20-25°C (68-77 °F) ■ avoid excessive heat, cold and humidity
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 10mg..................... Cough suppressant
Phenylephrine HCl 5mg ............................. Nasal decongestant
temporarily relieves common cold and flu symptoms:
■ minor aches & pains
■ headache
■ sore throat
■ nasal congestion
■ fever
■ cough due to minor throat & bronchial irritation
Allergy Alert: acetamenophen may cause severe skin recations. Symptoms may include:
■ skin reddening ■ blisters ■ rash. if a skin reactions occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily 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
■ liver disease
■ diabetes
■ heart disease
■ thyroid disease
■ high blood pressure
■ trouble urinating due to enlarged prostate gland
■ persistent or chronic cough as occurs with smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
When using this product, do not exceed recommeded dosage.
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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ take only as directed- see OVERDOSE WARNING
■ do not exceed 8 softgels per 24 hrs.
| Adults and children age 12 yrs and over | take 2 softgels with water every 4 hrs. |
| Children 4 to under 12 yrs | ask a doctor |
| Children under 4 yrs | do not use |
■ store at room temperature between 20-25°C (68-77 °F)
■ avoid excessive heat, cold and humidity
Polyethylene Glycol400, Propylene Glycol, Povidone K30, purified water, Gelatin, Glycerol, Sorbitol Sorbitan solution, FD & C Red No. 40, FD &C Yellow No. 6.
Call 1-718-337-8733 or email: support@nuvicare.com
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84324-023-01 | Nuvicare DayTime Cold and Flu Softgel | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 1 | |
| 84324-023-01 | Nuvicare DayTime Cold and Flu Softgel | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84324-023 | 84324-023-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| WATER | 059QF0KO0R | IACT |
| Gelatin | 2G86QN327L | IACT |
| Sorbitol | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | 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 |
|---|---|---|---|---|---|---|
| Nuvicare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | NUVICARE LLC | bdc35570-c8df-4797-a13e-7f2479ec42b7 | 2025-06-09 | Warnings | 84324-023-01 84324-023 84324002301 6b80519a-1e97-464a-b7ce-baa26ede64db bdc35570-c8df-4797-a13e-7f2479ec42b7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.