FDA Label for Alka-seltzer Original
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- STOMACH BLEEDING WARNING
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- 25 COUNT BOX
- 30 COUNT BOX
Alka-seltzer Original Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc.. 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.
Active Ingredients
Anhydrous citric acid 1000 mg
Aspirin 325 mg (NSAID) *
nonsteroidal anti-inflammatory drug
Sodium bicarbonate (heat-treated) 1916 mg
Purpose
Antacid
Analgesic
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 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
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
It is especially important not
to use aspirin at 20 weeks or later in 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
• 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
Questions Or Comments?
1-800-986-0369 (Mon - Fri 9AM - 5PM EST)
Other
Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981
This product is packaged by Lil' Drug Store Products, Inc.,
9300 Earhart Lane SW, Cedar Rapids, IA 52404
1-877-507-6516 (M-F 8AM-4:30PM CST),
from a product manufactured by Bayer.
“Bayer, the Bayer Cross and Alka-Seltzer are registered
trademarks of Bayer, used with permission.” Product of Mexico
25 Count Box
Alka-
Seltzer ®
Buffered aspirin (NSAID) /
Pain reliever / fever reducer
Fast Relief of:
Headache
Backache
Body Aches
Muscle Pain
ORIGINAL FLAVOR
50 Effervescent Tablets
(25 - 2 count pouches)
Alka-
Seltzer ®
Buffered aspirin (NSAID) /
Pain reliever / fever reducer
Fast Relief of:
Headache
Backache
Body Aches
Muscle Pain
ORIGINAL FLAVOR
50 Effervescent Tablets
(25 - 2 count pouches)
30 Count Box
Alka-
Seltzer ®
Buffered aspirin (NSAID) /
Pain reliever / fever reducer
Fast Relief of:
Headache
Backache
Body Aches
Muscle Pain
ORIGINAL FLAVOR
60 Effervescent Tablets
(30 - 2 count pouches)
* Please review the disclaimer below.