FDA Label for Alka-seltzer Original
View Indications, Usage & Precautions
- DO NOT USE
- WARNINGS
- ASK A DOCTOR BEFORE USE IF
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USES
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- QUESTIONS OR COMMENTS?
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- FRONT AND BACK
Alka-seltzer Original Product Label
The following document was submitted to the FDA by the labeler of this product Impulsora Sahuayo, S.a. De C.v. 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.
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
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
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
Active Ingredients (In Each Tablet)
Citric acid
Aspirin (NSAID)*
Sodium bicarbonate (heat-treated)
*nonsteroidal anti-inflammatory drug
Purpose
Citric acid 1000 mg...............................….……Antacid
Aspirin 325 mg (NSAID)*…..………………….…………..Analgesic
Sodium bicarbonate (heat-treated) 1916 mg.……………...Antacid
*nonsteroidal anti-inflammatory drug
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
Ask A Doctor Or Pharmacist Before Use If You Are
● presently taking a prescription drug.
Antacids mayinteract with certain prescription drugs.
● taking a prescription drug for diabetes, gout, or arthritis
When Using This Product
do not exceed recommended dosage
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
Questions Or Comments?
1-800-986-0369 (Mon – Fri 9AM –5PM EST)
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
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
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
none
* Please review the disclaimer below.