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Alka-Seltzer Original by Your Safety Company

Medically reviewed on March 14, 2018

Dosage form: tablet, effervescent
Ingredients: ANHYDROUS CITRIC ACID 1000mg, ASPIRIN 325mg, SODIUM BICARBONATE 1916mg
Labeler: Your Safety Company
NDC Code: 70262-304

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® Original

Drug Facts

Active ingredients (in each tablet)Purpose
nonsteroidal anti-inflammatory drug
Anhydrous citric acid 1000 mgAntacid
Aspirin 325 mg (NSAID)Analgesic
Sodium bicarbonate (heat-treated) 1916 mgAntacid

Uses

for the temporary relief of:

  • heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
  • upset stomach with headache from overindulgence in food or drink
  • headache, body aches, and pain alone

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

Do not use
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

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
  • you have a sodium-restricted diet

Ask a doctor or pharmacist before use if you are
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • taking a prescription drug for diabetes, gout, or arthritis

When using this product do not exceed recommended dosage

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
  • symptoms get worse or last more than 10 days
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
  • new symptoms occur

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

Directions

‚óŹ fully dissolve 2 tablets in 4 ounces of water before taking

adults and children 12 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 8 tablets in 24 hours
adults 60 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 4 tablets in 24 hours
children under 12 yearsconsult a doctor

Other information
  • each tablet contains: sodium 567 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients

none

Questions or comments?

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

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 50 Pouch Box

Alka-
Seltzer®

Anhydrous citric acid / Antacid
Aspirin (NSAID) / Analgesic
Sodium bicarbonate / Antacid

Fast Relief of:
Heartburn
Upset Stomach
Acid Indigestion
with Headache
Body Aches

ORIGINAL

EFFERVESCENT TABLETS

ALKA-SELTZER ORIGINAL 
anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70262-304(NDC:0280-4000)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID1000 mg
ASPIRIN (ASPIRIN) ASPIRIN325 mg
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE1916 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorImprint CodeALKA;SELTZER
Contains    
Packaging
#Item CodePackage Description
1NDC:70262-304-5050 POUCH in 1 BOX
12 TABLET, EFFERVESCENT in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/15/2016
Labeler - Your Safety Company (050622331)
Establishment
NameAddressID/FEIOperations
Your Safety Company050622331RELABEL(70262-304)

 
Your Safety Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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