Alka-seltzer Plus ®

Alka-seltzer Plus ®
SPL v9
SPL
SPL Set ID 78537dcf-b157-4b67-a8b2-5cb144815166
Route
ORAL
Published
Effective Date 2014-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg) Chlorpheniramine (2 mg) Phenylephrine (7.8 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Aspartame Calcium Silicate Dimethicone Docusate Sodium Mannitol Povidone Sodium Benzoate Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: ALKA;SELTZER;PLUS Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2008-04-10 Until 2019-12-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these symptoms due to a cold:
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1

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
Section 53414-9

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.

Section 55105-1
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
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
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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.

Other Information
  • each tablet contains: sodium 474 mg
  • Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
  • store at room temperature. Avoid excessive heat.
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.

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions Or Comments?

1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
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
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
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium-restricted diet
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 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
  • nervousness, dizziness, or sleeplessness occurs
Principal Display Panel 36 Tablet Carton

Alka-

Seltzer

PLUS ®

Aspirin (NSAID) / Pain reliever-

fever reducer • Chlorpheniramine

maleate / Antihistamine • Phenylephrine

bitartrate / Nasal decongestant

COLD

FORMULA

SPARKLING

ORIGINAL

Nasal Congestion • Runny Nose

Headache & Body Ache

Sore Throat • Sinus Pressure

36 EFFERVESCENT TABLETS

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these symptoms due to a cold:
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

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
Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
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
Allergy Alert (Allergy alert)

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Reye's Syndrome (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.

Other Information (Other information)
  • each tablet contains: sodium 474 mg
  • Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
  • store at room temperature. Avoid excessive heat.
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions Or Comments? (Questions or comments?)

1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stomach Bleeding Warning (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
Ask A Doctor Before Use If (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
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium-restricted diet
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 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
  • nervousness, dizziness, or sleeplessness occurs
Principal Display Panel 36 Tablet Carton (PRINCIPAL DISPLAY PANEL - 36 Tablet Carton)

Alka-

Seltzer

PLUS ®

Aspirin (NSAID) / Pain reliever-

fever reducer • Chlorpheniramine

maleate / Antihistamine • Phenylephrine

bitartrate / Nasal decongestant

COLD

FORMULA

SPARKLING

ORIGINAL

Nasal Congestion • Runny Nose

Headache & Body Ache

Sore Throat • Sinus Pressure

36 EFFERVESCENT TABLETS

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)