FDA Label for Critical Care Aspirin To Go
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (PER POWDER)
- PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- STOMACH BLEEDING WARNING
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 325 MG POUCH LABEL
Critical Care Aspirin To Go Product Label
The following document was submitted to the FDA by the labeler of this product Breakthrough 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.
Other
Drug Facts
Do not use if pouch is torn or open |
distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202
Active Ingredient (Per Powder)
Aspirin 325mg (NSAID)
nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
Temporarily relieves:
- headache
- toothache
- pain of colds
- muscle pain
- menstrual pain
- minor pain of arthritis
Reye's Syndrome
Children and teenagers who have or are recovering from chickenpox 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 longer than directed
Otc - Do Not Use
Do not use if you are allergic to aspirin or 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription for:
- gout
- diabetes
- arthritis
Stop Use And Ask A Doctor If
- an allergic reaction occurs (seek medical help right away)
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever lasts more than 3 days
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
- 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
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
adults and children 12 years and over:
- see instructions in red box for opening packet
- place 1-2 powders on the tongue and swallow with or without water
- repeat every 4-6 hours, while symptoms persist
- do not take more than 8 powders in 24 hours
children under 12 years: ask a doctor
Inactive Ingredients
acesulfame potassium, citric acid, flavor, glucose, sucralose
Questions?
1-888-998-7436 (Mon-Fri 9AM-5PM MDT)
Principal Display Panel - 325 Mg Pouch Label
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NO
WATER
REQUIRED
POUR DIRECTLY IN MOUTH
SEE OPENING INSTRUCTIONS ON BACK PANEL
CRITICAL
CARE
325
mg
URGENT Rx®
ASPIRIN
TO-GO™
ASPIRIN (NSAID) /
PAIN RELIEVER
lemon-lime
distributed by UrgentRx
1 POWDER PACK
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