FDA Label for Crane Safety Aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- OTHER
- 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?
- CRANE SAFETY ASPIRIN LABEL
Crane Safety Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Thompson. 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 (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.
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.
Other
Allergy alert:
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- 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
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:
Do Not Use
- if you have ever had an allergic reaction to aspirin or any other pain reliever/ fever reducer
- if you ever had an allergic reactioin 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
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug for
- gout
- diabetes
- arthritis
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
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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 or 3 tablest every 6 hours, not to exceed 12 tablets in 24 hours.
Children under 12 years:
Do not give to children under 12 years of age unless directed by a doctor..
Other Information
- use by expiration date on package
- store at 77°F (25°C); excursions permitted between 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*, polyethylene glycol*, propylene glycol*, titanium dioxide*
may contain*
Questions Or Comments?
877.506.4291
Crane Safety Aspirin Label
5 Grain (325 mg)
ASPIRIN
PainReliever/Fever Reducer (NSAID)
CRANE Safety®
Pull To Open
This Package Is For Households Without Young Children.
Aches, Fever
Aspirin (NSAID) 325 mg
100 Tablets
Tamper Evident
Sealed Packets
* Please review the disclaimer below.