ALKA-SELTZER PLUS COLD DAY AND NIGHT POWERMAX GELS- acetaminophen, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate 
Bayer HealthCare LLC.

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Alka-Seltzer Plus Max Strength Sinus congestion & Pain Day & Night PowerMax gels

Alka-Seltzer Plus® Maximum Strength Sinus Congestion & Pain Day PowerMax® Gels

Drug Facts

Active ingredients (in each tablet)

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

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

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

Uses

temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal congestion

· sinus congestion and pressure

· temporarily reduces fever

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

● 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

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

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

When using this product do not exceed recommended dosage

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, 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 right away.

Directions

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

● store at room temperature. Avoid temperatures above 40ºC (104ºF).

SPL

FD&C yellow #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? 1-800-986-0369 (Mon-Fri 9AM -5PM EST)

Package Display Label

ASP Plus 16Alka-Seltzer

PLUS®

Maximum Strength Sinus Congestion & Pain Day & Night PowerMax Gels

ALKA-SELTZER PLUS COLD DAY AND NIGHT POWERMAX GELS 
acetaminophen, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0099
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0099-011 in 1 CARTON; Type 0: Not a Combination Product09/14/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 CAPSULE 12 
Part 21 CAPSULE
Part 1 of 2
ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS, CONGESTION AND PAIN POWER MAX GELS 
acetaminophen, dextromethorphan hydrobromide , phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:0280-0095
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
SHELLAC (UNII: 46N107B71O)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize17mm
FlavorImprint Code ASP;CC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 BLISTER PACK
18 in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/01/2021
Part 2 of 2
ALKA SELTZER PLUS MAXIMUM STRENGTH SINUS, ALLERGY AND COUGH POWER MAX GELS 
acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:0280-0097
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SHELLAC (UNII: 46N107B71O)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
SORBITAN (UNII: 6O92ICV9RU)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (Elliptical) Size17mm
FlavorImprint Code ASP;N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 BLISTER PACK
14 in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/01/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2023
Document Id: 0c3d891d-0f75-4fb8-e063-6294a90aad3a
Set id: f6c73f61-f4fc-377f-e053-6294a90a3797
Version: 9
Effective Time: 20231211
 
Bayer HealthCare LLC.