Indications and uses
temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor • throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor • throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 Softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Drug Facts
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
temporarily relieves common cold/flu symptoms:
• nasal congestion
• cough due to minor
• throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 Softgels 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
Allergy Alert:Acetaminophen may cause severe skin reactions. Symptoms may
• include:
• skin reddening
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are
• not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask a 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
• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with rash or headache that lasts.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
take only as directed do not exceed 8 softgels per 24 hrs
| adults & children 12 yrs & over | 2 Softgels with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
• store between 20-25°C (68-77°F).
Avoid high humidity and excessive heat.
Protect from light.
1-800-373-6981 (toll-free)
anhydrous citric acid*, butylated hydroxyanisole*, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methyl paraben*, polyethylene glycol-400, propylene glycol*, propylparaben*, purified water, povidone, sorbitol*. *may contain these ingredients
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
ValuRx
Compare to the Active Ingredients in Alka-Seltzer Plus® Cold & Flu Maximum Strengths
Nighttime Cold & Flu
Multi-Symptom Relief
Acetaminophen
Dextromethorphan HBr
Phenylephrine HCl
• Headache, Fever, Sore Throat,
• Minor Aches & Pain
• Nasal Congestion,
• Sinus Pressure
• Cough
Carton
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 6 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 6 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0611419406224 | GTIN-13: 0611419406224 EAN-13: 0611419406224 GTIN-12: 611419406224 UPC-A: 611419406224 GTIN storage (14 digits): 00611419406224 | Carton.jpg |
| QR code link | QR Code | Carton.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83059-0113-1 | Daytime Cold and Flu Multi Symptom Relief | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 6 | |
| 83059-0113-1 | Daytime Cold and Flu Multi Symptom Relief | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83059-0113 | 83059-0113-1 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2024-12-26 | full-release | 2026-06-01 00:48:58 |
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 |
|---|---|---|---|---|---|---|
| 5a5f6bcf-e9de-4b58-e063-6394a90a5193 | 20eb90a6-5a0d-462e-8a6c-7ad5872cc8e7 | 2026-08-31 | Warnings | 20eb90a6-5a0d-462e-8a6c-7ad5872cc8e7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.