Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels

Manufacturer
Bayer HealthCare LLC. | Bayer Healthcare LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:32:11

Label at a glance#

ProductAlka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

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

· 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.

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

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 SAFETY INFORMATION

Other information

store at room temperature. Avoid excessive heat above 40ºC (104ºF).

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C yellow No.6, ferric oxide, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions or Comments

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN9
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD9
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500583493GTIN-13: 0016500583493
EAN-13: 0016500583493
GTIN-12: 016500583493
UPC-A: 016500583493
GTIN storage (14 digits): 00016500583493
ASP Sinus Congestion Pain PMG 24ct.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0095-01Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels2 in 1 CARTONCAPSULE, LIQUID FILLED29
0280-0095-01Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED89
0280-0095-02Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED129
0280-0095-02Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels2 in 1 CARTONCAPSULE, LIQUID FILLED29

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00950280-0095-02, 0280-0095-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
ndc (package): 0280-0095-01
ndc (package): 0280-0095-02
ndc (product): 0280-0095
ndc11 (package): 00280009502
ndc11 (package): 00280009501
spl id: 47e31806-7f5d-9a08-e063-6394a90ab71f
spl set id: e07931fc-f753-1aeb-e053-2a95a90ada3f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.