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Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night

Medically reviewed on June 19, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; PHENYLEPHRINE HYDROCHLORIDE 5mg, ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: Bayer HealthCare LLC.
NDC Code: 0280-1610

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.

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day & Night Liquid Gels

Do not take these products at the same time.

Drug Facts

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels

Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Purposes
Pain reliever/fever reducer
Cough suppressant

Nasal decongestant

Uses
· temporarily relieves these symptoms due to a cold or flu:
· nasal congestion · sinus congestion and pressure
· headache · minor aches and pains
· cough · sore throat
· helps clear nasal passages and shrinks swollen membranes

· 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 you have

● liver disease ● heart disease ● high blood pressure

● thyroid disease ● diabetes

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

Directions

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 FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, 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)

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels

Drug Facts

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Uses

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

· nasal congestion · sinus congestion and pressure

· headache · minor aches and pains

· cough · sore throat

· runny nose · sneezing

· helps clear nasal passages and shrinks swollen membranes

· 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.

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

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

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

· 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 FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, 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)

ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS CONGESTION AND COUGH DAY AND NIGHT 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1610
Packaging
#Item CodePackage Description
1NDC:0280-1610-201 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 12 
Part 24 BLISTER PACK 16 
Part 1 of 2
ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS CONGESTION AND COUGH DAY 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
SHELLAC 
SORBITAN 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
GLYCERIN 
GELATIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM HYDROXIDE 
Product Characteristics
ColororangeScoreno score
ShapeOVALSize20mm
FlavorImprint CodeAS;SC
Contains    
Packaging
#Item CodePackage Description
12 BLISTER PACK in 1 CARTON
16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/12/2017
Part 2 of 2
ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS CONGESTION AND COUGH NIGHT 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
GELATIN 
GLYCERIN 
SHELLAC 
SODIUM HYDROXIDE 
TITANIUM DIOXIDE 
POVIDONE 
POLYETHYLENE GLYCOLS 
SORBITOL 
SORBITAN 
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint CodeAS;SC
Contains    
Packaging
#Item CodePackage Description
12 BLISTER PACK in 1 CARTON
14 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/12/2017
Labeler - Bayer HealthCare LLC. (112117283)

 
Bayer HealthCare LLC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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