FDA Label for Chewable Aspirin
View Indications, Usage & Precautions
Chewable Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Genuine First Aid Llc. 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 Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Analgesic/antipyretic
Uses
temporary relief of minor aches, pains and headaches
to reduce fever associated with colds, sore throats, teething
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.
Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.
Do Not Use
if you are allergic to aspirin or any other pain relievers/fever reducers
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
for at least 7 days after a tonsillectomy or oral surgery
Ask A Doctor Before Use If You Have:
asthma
stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems
a child experiencing arthritis pain
if you are;
allergic to aspirin
taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis
Stop Use And Ask A Doctor If:
an allergic reaction occurs, Seek medical help right away
pain or fever persists
new or unexpected symptoms occur
redness or swelling is present
ringing in ears or loss of hearing occurs
Otc - Pregnancy Or Breast Feeding
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 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 immediately.
Directions
Do not use more than directed
Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor.
Children Under 12 years: Consult a doctor.
Storage And Handling
Store at room temperature
tamper evident sealed packets
do not use any opened or torn packets
Inactive Ingredients
flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose
Description
MADE IN USA
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
Package Label.Principal Display Panel
2 Tablets
GENUINE FIRST AID.
Chewable Aspirin 81mg
* Please review the disclaimer below.