![ALKA SELTZER ORIGINAL (ANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]](https://medic.hrt.org//dailymed/images/fbf52eee-b307-4640-8f90-909bebe54a42/Alka Seltzer Original.jpg)
| NDC | 67751-143-01, 67751-143-02 |
| Set ID | fbf52eee-b307-4640-8f90-909bebe54a42 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Navajo Manufacturing Company Inc. |
| Generic Name | |
| Product Class | Anti-coagulant |
| Product Number | |
| Application Number | PART343 |
- Drug Facts
- Active ingredients (in each tablet)
- Uses
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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 directedDo 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 ingredientsAsk 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 dietAsk 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 arthritisStop 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 -
Directions
fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours children under 12 years consult a doctor - Other information
- Inactive ingredients
- Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ALKA SELTZER ORIGINAL
anhydrous citric acid, aspirin, sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-143(NDC:0280-4000) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 1916 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code ALKA;SELTZER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-143-01 1 in 1 CARTON 09/16/2016 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67751-143-02 2 in 1 CARTON 09/16/2016 2 4 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/16/2016 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-143) , repack(67751-143)
