FDA Label for Alka-seltzer Plus Cold Medicine Sparkling Original

Other

Drug Facts

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

Otc - Purpose

Uses

• temporarily relieves these symptoms due to a cold:
• temporarily reduces fever

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.

Otc - Do Not Use

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
  
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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)

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

Principal Display Panel - 36 Tablet Carton - alka seltzer 01