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Alka-Seltzer Plus Cold Medicine Sparkling Original

Dosage form: tablet, effervescent
Ingredients: ASPIRIN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE BITARTRATE 7.8mg
Labeler: Bayer HealthCare LLC.
NDC Code: 0280-1400

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 ® Cold Medicine Sparkling Original

Drug Facts

Active ingredients (in each tablet)Purposes
nonsteroidal anti-inflammatory drug
Aspirin 325 mg (NSAID) Pain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine bitartrate 7.8 mgNasal decongestant

Uses
  • temporarily relieves these symptoms due to a cold:
  • 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
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis
  • taking sedatives or tranquilizers

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

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

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

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)

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

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

ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL 
aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1400
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE BITARTRATE (PHENYLEPHRINE) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
ASPARTAME 
CALCIUM SILICATE 
DIMETHICONE 
DOCUSATE SODIUM 
MANNITOL 
POVIDONES 
SODIUM BENZOATE 
SODIUM BICARBONATE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorImprint CodeALKA;SELTZER;PLUS
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-1400-126 POUCH in 1 CARTON
12 TABLET, EFFERVESCENT in 1 POUCH
2NDC:0280-1400-2010 POUCH in 1 CARTON
22 TABLET, EFFERVESCENT in 1 POUCH
3NDC:0280-1400-3216 POUCH in 1 CARTON
32 TABLET, EFFERVESCENT in 1 POUCH
4NDC:0280-1400-3618 POUCH in 1 CARTON
42 TABLET, EFFERVESCENT in 1 POUCH
5NDC:0280-1400-4824 POUCH in 1 CARTON
52 TABLET, EFFERVESCENT in 1 POUCH
6NDC:0280-1400-7236 POUCH in 1 CARTON
62 TABLET, EFFERVESCENT in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/10/2008
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2017
 
Bayer HealthCare LLC.

← See all Alka-Seltzer Plus Cold Medicine Sparkling Original brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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