NDC | 70262-304-50 |
Set ID | 3b37ab81-2717-4afd-8f66-89a7bed1140e |
Category | HUMAN OTC DRUG LABEL |
Packager | Your Safety Company |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- 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
- if you have ever had an allergic reaction to this product or any of its ingredients
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
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
Directions
● fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 12 years and over 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
- each tablet contains: sodium 567 mg
- store at room temperature. Avoid excessive heat.
- Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 Pouch Box
Alka-
Seltzer®Anhydrous citric acid / Antacid
Aspirin (NSAID) / Analgesic
Sodium bicarbonate / AntacidFast Relief of:
Heartburn
Upset Stomach
Acid Indigestion
with Headache
Body AchesORIGINAL
EFFERVESCENT TABLETS
- INGREDIENTS AND APPEARANCE
ALKA-SELTZER ORIGINAL
anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70262-304(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) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1916 mg 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:70262-304-50 50 in 1 BOX 1 2 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 03/15/2016 Labeler - Your Safety Company (050622331) Establishment Name Address ID/FEI Business Operations Your Safety Company 050622331 RELABEL(70262-304)