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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Combo ASP 24Alka-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:0280-0098
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0098-011 in 1 CARTON; Type 0: Not a Combination Product09/14/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 CAPSULE 16 
Part 22 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 finalpart34107/01/2021
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 finalpart34109/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 6/2022
Document Id: e28778f5-1338-ed7f-e053-2a95a90afcf2
Set id: e2877488-3539-cba2-e053-2995a90a6005
Version: 4
Effective Time: 20220628
 
Bayer HealthCare LLC.