ALKA-SELTZER- anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent 
Lil' Drug Store Products, Inc

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®

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 relief of:

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

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

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

Inactive ingredients

none

Questions or comments?

1-800-986-0369 (Mon - Fri 9AM - 5PM EST) or www.alkaseltzer.com

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

See new warnings information

Alka-
Seltzer
®

Anhydrous Citric Acid/Antacid
Aspirin (NSAID)/Analgesic
Sodium Bicarbonate/Antacid

FAST
RELIEF
OF:
Acid Indigestion
Upset Stomach
Heartburn with
Headache
Body Aches

ORIGINAL

2
EFFERVESCENT
TABLETS

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton
ALKA-SELTZER 
anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9703
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid1000 mg
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin325 mg
Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate1916 mg
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize14mm
FlavorImprint Code Alka;Seltzer
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9703-11 in 1 CARTON01/01/2000
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:66715-9703-22 in 1 CARTON01/01/2000
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:66715-9703-015 in 1 CARTON01/01/200012/31/2018
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/01/2000
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 1/2020
Document Id: ec2f68dd-fee3-46c6-a21f-7a1e8e8a06ec
Set id: fbfa46b6-1773-4053-b323-66f4321d6472
Version: 5
Effective Time: 20200103
 
Lil' Drug Store Products, Inc