FDA Label for First Aid Only Aspirin
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- ADULTS AND CHILDREN: (12 YEARS AND OLDER)
- CHILDREN UNDER 12 YEARS:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- FIRST AID ONLY ASPIRIN LABEL
First Aid Only Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Acme United Corporation. 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
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 •shock •asthma (wheezing)
If an allergic reaction occurs, stop use and seek medical help right away.
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 alcohol drinks every day while
using this product - take more or for a longer time than directed
Active Ingredient (In Each Tablet)
Aspirin (NSAID*) 325 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains associated with
- headache
- minor arthritis
- common cold
- menstrual cramps
- muscular aches
- backache
- toothache
Temporarily reduces fever.
Do Not Use
- If you are allergic to aspirinor any other pain reliever/fever reducer
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
Ask A Doctor Or Pharmacist Before Use If You Are
- taking prescription drugs for gout, diabetes or arthritis
When Using This Product
- take with food or milk if stomach upset occurs
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
- if ringing in the ears or loss of hearing occurs
- redness or swelling is present in the painful area
- any new symptoms appear
- an allergic reaction occurs. Seek medical help right away.
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.
Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless
directed by a doctor (see Warnings) - drink a full glass of water with each dose
Adults And Children: (12 Years And Older)
Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.
Children Under 12 Years:
Do not give to children under 12 years of age.
Other Information
- read all product information before using
- store at room temperature 59°-86°F (15°-30°C)
- avoid excessive heat and humidity
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive Ingredients
corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide
Questions Or Comments?
1-800-835-2263
First Aid Only Aspirin Label
First Aid Only Label
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