Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2026-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:51:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
· temporarily relieves these symptoms due to hay fever or other upper
respiratory allergies:
· runny nose · sneezing
· itching of the nose or throat · itchy, watery eyes
· temporarily relieves these symptoms due to a cold:
· minor aches and pains · headache · cough · sore throat
· nasal congestion · sinus congestion and pressure
· 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.
Do not use to sedate children
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 that occurs with excessive phlegm (mucus)
● 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
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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 D&C yellow No.10, FD&C blue No.1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
Questions or Comments
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka Seltzer Plus MAXIMUM STRENGTH
Sinus, Allergy & Cough PowerMax Gels
Acetaminophen / Pain Reliever-Fever Reducer
Dextromethorphan Hydrobromide / Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine Hydrochloride / Nasal Decongestant
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 10 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 10 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 10 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0097-01 | Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 10 | |
| 0280-0097-01 | Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 10 | |
| 0280-0097-02 | Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 10 | |
| 0280-0097-02 | Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 10 |
Products#
Every source-derived product name is available through these pages.
- Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels
- Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride
- FD&C BLUE NO. 1
- SODIUM HYDROXIDE
- ACETAMINOPHEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- D&C YELLOW NO. 10
- GELATIN
- POVIDONE
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SHELLAC
- SORBITAN
- TITANIUM DIOXIDE
- SORBITOL
- POTASSIUM ALUMINUM DISILICATE
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0097 | 0280-0097-02, 0280-0097-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 9 | 2024-08-20 | full-release | 2026-06-01 00:17:31 |
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 Sinus, Allergy And Cough Power Max Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | e17eb929-209d-a2d1-e053-2a95a90a4cf3 | 2026-01-08 | Warnings | 0280-0097-02 0280-0097-01 0280-0097 00280009702 00280009701 47e323f5-7f72-a31e-e063-6394a90af3a9 e17eb929-209d-a2d1-e053-2a95a90a4cf3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
