ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL- aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent

Alka-Seltzer Plus Cold Medicine Sparkling Original by

Drug Labeling and Warnings

Alka-Seltzer Plus Cold Medicine Sparkling Original by is a Otc medication manufactured, distributed, or labeled by R J General Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

• temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • headache
  • 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
  • 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)

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 60 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

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL 
aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70264-015(NDC:0280-1400)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE BITARTRATE	7.8 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM SILICATE (UNII: S4255P4G5M)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	25mm
Flavor		Imprint Code	ALKA;SELTZER;PLUS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70264-015-01	30 in 1 CARTON	04/10/2008
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/10/2008

Labeler - R J General Corporation (122542830)

Establishment
Name	Address	ID/FEI	Business Operations
R J General Corporation		122542830	REPACK(70264-015)