ALKA SELTZER PLUS MAXIMUM STRENGTH SINUS, ALLERGY AND COUGH POWER MAX GELS- acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled 
Bayer HealthCare LLC.

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Alka-Seltzer Plus® Maximum Strength Sinus, Allergy & Cough PowerMax Gels

Drug Facts

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

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

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

● 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

● 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

When using this product

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 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)

Sinus Allergy Green Gel ASP

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

ALKA SELTZER PLUS MAXIMUM STRENGTH SINUS, ALLERGY AND COUGH POWER MAX GELS 
acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0097
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITOL (UNII: 506T60A25R)  
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (Elliptical) Size17mm
FlavorImprint Code ASP;N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0097-022 in 1 CARTON08/25/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0280-0097-012 in 1 CARTON08/25/2021
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/25/2021
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2023
Document Id: 0c3de498-4e7d-6a1f-e063-6294a90a8c00
Set id: e17eb929-209d-a2d1-e053-2a95a90a4cf3
Version: 8
Effective Time: 20231211
 
Bayer HealthCare LLC.