Alka-Seltzer Plus Maximum Strength Day Cold and Flu
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:19:49
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
· temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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 followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly.
OTC - DO NOT USE SECTION
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.
● if you have ever had an allergic reaction to this product or any of its
ingredients
● in children under 12 years of age
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes
● cough with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage
OTC - STOP USE SECTION
Stop use and ask a doctor if
· pain, cough, or nasal congestion 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.
These could be signs of a serious condition.
· nervousness, dizziness, or sleeplessness occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. 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.
DOSAGE & ADMINISTRATION SECTION
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 10 capsules in 24 hours or as
directed by a doctor.
· children under 12 years: do not use
Other information
Other information
· store at room temperature. Avoid excessive heat above 40ºC
(104ºF).
INACTIVE INGREDIENT SECTION
Inactive ingredients FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
Carton 20
Alka-Seltzer PLUS
MAXIMUM STRENGTH
Cold
& Flu
DAY NON-DROWSY
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Dextromethorphan Hydrobromide / Cough Suppressant
Phenylephrine HCl / Nasal Decongestant
- Cough
- Nasal Congestion
- Headache & Body Ache
- Sore Throat
- Sinus Pressure
20 LIQUID GELS (Liquid Filled Capsules)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 7 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 7 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 7 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500555308 | GTIN-13: 0016500555308 EAN-13: 0016500555308 GTIN-12: 016500555308 UPC-A: 016500555308 GTIN storage (14 digits): 00016500555308 | 86326256_Alka-Seltzer Plus Max Strength Day Cold Flu LG 20 ct.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1590-20 | Alka-Seltzer Plus Maximum Strength Day Cold and Flu | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 7 | |
| 0280-1590-20 | Alka-Seltzer Plus Maximum Strength Day Cold and Flu | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 7 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Maximum Strength Day Cold and Flu
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- GLYCERIN
- WATER
- SHELLAC
- SODIUM HYDROXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- GELATIN
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- SORBITAN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-1590 | 0280-1590-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SHELLAC | 46N107B71O | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5172dc01-4e7f-3307-e054-00144ff8d46c | 2025-12-04 | Warnings | 0280-1590-20 0280-1590 00280159020 45267943-6d50-45dd-e063-6294a90ab025 5172dc01-4e7f-3307-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
