NDC 70264-015 Alka-seltzer Plus Cold Medicine Sparkling Original

Product Information

Alka-seltzer Plus Cold Medicine Sparkling Original is product labeled by R J General Corporation. The product's dosage form is and is administered via form.

Product Code70264-015
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Alka-seltzer Plus Cold Medicine Sparkling Original
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
R J General Corporation
Labeler Code70264
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-10-2008
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2019
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Alka-seltzer Plus Cold Medicine Sparkling Original?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)25 MM
Imprint(s)ALKA;SELTZER;PLUS
Score1

Product Packages

NDC 70264-015-01

Package Description: 30 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Alka-seltzer Plus Cold Medicine Sparkling Original Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ASPIRIN (UNII: R16CO5Y76E)
  • ASPIRIN (UNII: R16CO5Y76E) (Active Moiety)
  • CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z)
  • CHLORPHENIRAMINE (UNII: 3U6IO1965U) (Active Moiety)
  • PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57)
  • PHENYLEPHRINE (UNII: 1WS297W6MV) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1536840 - aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
  • RxCUI: 1536840 - ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • 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)
  • POVIDONES (UNII: FZ989GH94E)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)

* Please review the disclaimer below.

Alka-seltzer Plus Cold Medicine Sparkling Original Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981


Otc - Purpose



Active ingredients (in each tablet)Purposes
Aspirin 325 mg (NSAID)

nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine bitartrate 7.8 mgNasal 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

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 - 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


* Please review the disclaimer below.