NDC | 35418-233-67 |
Set ID | b4549a8e-30db-4075-8a3c-aec3a26d2c29 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZEE MEDICAL |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
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
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
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
ORIGINAL FLAVOR • EFFERVESCENT
Zee-Seltzer™
ANTACID & PAIN RELIEVERAspirin (NSAID) / Pain reliever
Citric acid / Antacid
Sodium bicarbonate / AntacidNBE
NATIONAL
BRAND
EQUIVALENT
COMPARE TO ACTIVE
INGREDIENTS OF ALKA-SELTZER®*FAST RELIEF
▼ HEARTBURN
▼ ACID INDIGESTION
▼ SOUR STOMACH with HEADACHE
▼ BODY ACHES and PAINS36 EFFERVESCENT TABLETS
ZEE
1408
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INGREDIENTS AND APPEARANCE
ZEE-SELTZER ANTACID AND PAIN RELIEVER
aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-233 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 325 mg Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 1000 mg Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate 1916 mg Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 25mm Flavor Imprint Code C11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35418-233-67 18 in 1 CARTON 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 08/14/2006 Labeler - ZEE MEDICAL (009645623)