Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night

Manufacturer
Bayer HealthCare, LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:00

Label at a glance#

ProductAlka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night
Active ingredientGUAIFENESIN, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure19 sections

Indications and uses

Uses · helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive · temporarily relieves these symptoms due to a cold or flu: · nasal congestion · sinus congestion and pressure · minor aches and pains · headache · cough · sore throat · temporarily reduces fever

Dosage and administration

Directions · do not take more than the recommended dose · do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 6 capsules in 12 hours or as directed by a doctor. · children under 12 years: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Do not take these products at the same time.

Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Day PowerMax® Gels

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule) Purposes

Acetaminophen 325 mg…………….……….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

Guaifenesin 200 mg…………………………………………..Expectorant

Phenylephrine hydrochloride 5 mg………………...Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses

· helps loosen phlegm (mucus) and thin bronchial secretions to rid

the bronchial passageways of bothersome mucus and make coughs

more productive

· temporarily relieves these symptoms due to a cold or flu:

· nasal congestion · sinus congestion and pressure

· minor aches and pains · headache

· cough · sore throat

· temporarily reduces fever

Warnings

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

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

chronic bronchitis or emphysema

● cough with excessive phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

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 fever, rash or headache that lasts.

These could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4 hours

after the last Night dose before starting Day product

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 6 capsules in 12 hours or as

directed by a doctor.

· children under 12 years: do not use

Other information

OTHER SAFETY INFORMATION

Other information

· store at 15°- 25°C (59° - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C red No. 40, gelatin, glycerin, lecithin, medium chain triglycerides, 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)

SPL UNCLASSIFIED SECTION

Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Night PowerMax® Gels

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule) Purposes

Acetaminophen 325 mg…………….… ……...Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg…… ………Cough suppressant

Doxylamine succinate 6.25 mg…………… ………………...Antihistamine

Phenylephrine hydrochloride 5 mg.....…… ………...Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache

· nasal and sinus congestion · cough

· sore throat · runny nose · sneezing

· temporarily reduces fever

Warnings

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.

Do not use

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes ● glaucoma

● 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

Ask a doctor or pharmacist before use if you are

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

When using this product

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4

hours after the last Day dose before starting Night product

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 4 capsules in 12 hours or as

directed by a doctor.

· children under 12 years: do not use

Other information

OTHER SAFETY INFORMATION

Other information

· store at 15° - 25°C (59° - 77°F)

Inactive ingredients

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

OTC - QUESTIONS SECTION

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

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK5
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSN5
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN5
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN5
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD5
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD5
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSY5
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY5
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500584216GTIN-13: 0016500584216
EAN-13: 0016500584216
GTIN-12: 016500584216
UPC-A: 016500584216
GTIN storage (14 digits): 00016500584216
ASP Cough Mucus COngestion Day Night PMG 16ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0062-01Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night1 in 1 CARTONKIT15

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00620280-0062-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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 Cough, Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.a6b8dc25-0fb9-1823-e053-2a95a90adf932025-12-04WarningsExact identifier
ndc (package): 0280-0062-01
ndc (product): 0280-0062
ndc11 (package): 00280006201
spl id: 45263262-6498-654f-e063-6394a90a4683
spl set id: a6b8dc25-0fb9-1823-e053-2a95a90adf93

Reported adverse events (FAERS/openFDA)#

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