Alka-Seltzer Plus® Cold & Cough Effervescent Tablets

Alka-Seltzer Plus® Cold & Cough Effervescent Tablets

Drug Labeling and Warnings

Drug Details

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ALKA-SELTZER PLUS COLD AND COUGH- aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent 
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® Cold & Cough Effervescent Tablets

Drug Facts

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

Uses

 temporarily relieves these symptoms due to a cold with cough:

 ·minor aches and pains  ·headache  ·cough

 ·runny nose  ·nasal and sinus congestion

 ·sneezing  ·sore throat

 ·temporarily reduces fever

Warnings

Reye’s syndrome: Children and teenagers who have or are

recovering from chicken pox or flu-like symptoms should not use this

product. When using this product, if changes in behavior with nausea

and vomiting occur, consult a doctor because these symptoms could be

an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may

include:

 hives  facial swelling  asthma (wheezing)  shock

Stomach bleeding warning: This product contains an NSAID, which

may cause severe stomach bleeding. The chance is higher if you

● are age 60 or older

● have had stomach ulcers or bleeding problems

● take a blood thinning (anticoagulant) or steroid drug

● take other drugs containing prescription or nonprescription NSAIDs

(aspirin, ibuprofen, naproxen, or others)

● have 3 or more alcoholic drinks every day while using this product

● take more or for a longer time than directed

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

● if you are allergic to aspirin or any other pain reliever/fever reducer

● 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

● stomach bleeding warning applies to you

● you have a history of stomach problems, such as heartburn

● you have high blood pressure, heart disease, liver cirrhosis,

or kidney disease

● you are taking a diuretic

● you have:

● asthma ● diabetes ● thyroid disease ● 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

● a sodium-restricted diet

When using this product

do not exceed recommended dosage

 may cause marked drowsiness

● avoid alcoholic drinks

● excitability may occur, especially in children

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

Stop use and ask a doctor if

● an allergic reaction occurs. Seek medical help right away.

● you experience any of the following signs of stomach bleeding

● feel faint ● vomit blood ● have bloody or black stools

● have stomach pain that does not get better

 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

 ringing in the ears or a loss of hearing occurs

 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.

It is especially important not to use aspirin during the last 3

months of pregnancy unless definitely directed to do so by a

doctor because it may cause problems in the unborn child or

complications during delivery.

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Directions

Directions

● adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours

or as directed by a doctor.

● children under 12 years: do not use

Other information

Other information

each tablet contains: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat.

Inactive ingredients acesulfame potassium, anhydrous citric

acid, aspartame, calcium silicate, dimethicone, docusate sodium, FD&C

red #40, flavors, mannitol, povidone, sodium benzoate, sodium

bicarbonate

Questions or comments?

Questions or comments?1-800-986-0369 (Mon - Fri 9AM -

5PM EST)

Alka-Seltzer

PLUS®

Cold &

Cough

CITRUS

ASPIRIN (NSAID) / Pain Reliever/Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppresant

Phenylephrine Bitartrate/Nasal Decongestant

  • Cough
  • Nasal Congestion
  • Runny Nose
  • Headache & Body Ache
  • Sinus Pressure

20 EFFERVESCENT TABLETS

Package label

ALKA-SELTZER PLUS COLD AND COUGH 
aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0280-1555
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorCITRUSImprint Code ASP;CandC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0280-1555-2010 in 1 CARTON09/14/2018
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/14/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2018
 
Bayer HealthCare LLC.


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