FDA Label for Zee-seltzer Antacid And Pain Reliever
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- STOMACH BLEEDING WARNING
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 36 TABLET CARTON
Zee-seltzer Antacid And Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Zee Medical. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 mg | Antacid |
Sodium bicarbonate (heat-treated) 1916 mg | Antacid |
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 over | 2 tablets every 4 hours. Do not exceed 8 tablets in 24 hours |
60 years and over | 2 tablets every 4 hours. Do not exceed 4 tablets in 24 hours |
Children under 12 years | Ask 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
* Please review the disclaimer below.