Zee-seltzer Antacid And Pain Reliever
FDA Label NDC 35418-233

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zee Medical for the product Zee-seltzer Antacid And Pain Reliever (NDC 35418-233). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, otc - do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by ZEE MEDICAL, INC., Irvine, CA 92606

Otc - Purpose

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

nonsteroidal anti-inflammatory drug

)
Pain reliever
Citric acid 1000 mgAntacid
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

Reye's Syndrome

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

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
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed

Otc - Do Not Use

Do not use: if you have ever had an allergic reaction to 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 are taking a diuretic
  • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease

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

Stop Use And Ask A Doctor If

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any signs of stomach bleeding: (feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better)
  • pain lasts more than 10 days or gets worse
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • any new symptoms appear

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

  • completely dissolve tablets in 4 ounces of water before taking
  • Adults and children 12 years and over2 tablets every 4 hours. Do not exceed 8 tablets in 24 hours
    60 years and over2 tablets every 4 hours. Do not exceed 4 tablets in 24 hours
    Children under 12 yearsAsk a doctor

Other Information

  • each tablet contains: sodium 540 mg
  • store at 15-25°C (59-77°F)
  • avoid excessive heat above 40°C (104°F)
  • in water, this tablet contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients

none

Questions?

1-800-841-8417 or zeemedical.com

Principal Display Panel - 36 Tablet Carton

ORIGINAL FLAVOR • EFFERVESCENT

Zee-Seltzer
ANTACID & PAIN RELIEVER

Aspirin (NSAID) / Pain reliever
Citric acid / Antacid
Sodium bicarbonate / Antacid

NBE
NATIONAL
BRAND
EQUIVALENT

COMPARE TO ACTIVE
INGREDIENTS OF ALKA-SELTZER®*

FAST RELIEF

HEARTBURN
ACID INDIGESTION
SOUR STOMACH with HEADACHE
BODY ACHES and PAINS

36 EFFERVESCENT TABLETS

ZEE

1408

Principal Display Panel (36 Tablet Carton)

Principal Display Panel (36 Tablet Carton)

* Please review the disclaimer below.