FDA Label for Aspirin 50 Ct
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLETS)
- PURPOSE
- USE
- REYE'S SYNDROME
- ALLERGY WARNING
- STOMACH BLEEDING WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- OTC - STOP USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 50 TABLET PACKET BOX
Aspirin 50 Ct Product Label
The following document was submitted to the FDA by the labeler of this product Jhk Inc Dba American Safety & First Aid. 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.
Other
Drug Facts
Stop use and ask a doctor if 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
- ringing in the ears or loss of hearing occurs
- pain or fever persists or gets worse
- new symptoms occur
- redness or swelling is present
Active Ingredient (In Each Tablets)
Aspirin 325 mg
Purpose
pain reliever/fever reducer
Use
temporarily relieves fever and minor aches and pains associated with:
- headache
- colds
- muscular aches
- toothache
- minor arthritis pain
- menstrual cramps
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 Warning
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach Bleeding Warning
This product contains a nonsteroidal anti-inflammatory drug (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 prescription or nonprescription drugs containing an NSAID (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
- with any other pain reliever/fever reducer
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
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 a history of stomach problems, such as heartburn
Otc - Stop Use
Stop use and ask a doctor if 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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
Otc - When Using
When using this product do not exceed recommended dose.
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 THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
Otc - 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Adults and children 12 years of age and older: Take 2 tablets with water every 4 hours as needed, not to exceed 12 tablets in 24 hours, or as directed by doctor Children under 12 years of age: Ask a doctor.
Other Information
- do not use if packet is opened or torn
- Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Inactive Ingredients
microcrytalline cellulose, povidone, pregelatinized starch
Questions?
1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
Principal Display Panel - 50 Tablet Packet Box
Product #1112
Aspirin
Pain Reliever/Fever Reducer (NSAID)
- Temporary relief from pain and fever
- Soothes muscle aches and minor
arthritis pain
These quality comfort tablets are formulated and packaged for use in
the workplace and meet ANSI Z308.1-2015 standards. They are
sealed in tamper-evident packets for safety and convenience.
50 Tablets • 2 Tablets Per Packet
Manufactured for American Safety & First Aid
Osceola, IN 46561
* Please review the disclaimer below.