FDA Label for First Aid Shot Therapy Pain Relief
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- REYE'S SYNDROME
- STOMACH BLEEDING WARNING
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 40 ML BOTTLE LABEL
First Aid Shot Therapy Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product First Aid Beverages, 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
Distributed by
First Aid Shot Therapy®
Burlingame, CA 94010
Otc - Purpose
Active ingredients | Purposes |
---|---|
Choline salicylate 650 mg (NSAID) nonsteroidal anti-inflammatory drug | Pain reliever |
Caffeine 65 mg | Pain reliever aid |
Uses
- headache
- muscle pain
- toothache
- menstrual pain
- pain of colds
- 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: contains salicylate
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 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 a longer time than directed
Otc - Do Not Use
Do not use if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
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 drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
Otc - When Using
When using this product limit use of caffeine containing drugs, foods, or drinks, because too much caffeine may cause nervousness, irritability, sleeplessness, and occasional rapid heartbeat
Stop Use And Ask A Doctor If
- an allergic reaction occurs (seek medical help right away)
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- redness or swelling is present
- new symptoms occur
- 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.
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:
- swallow the contents of one bottle
- repeat every 3-4 hours while symptoms persist
- do not take more than 6 bottles in 24 hours
- Children under 12 years: Do not use
Other Information
- keep from freezing
- avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients
Citric acid, natural and artificial flavors, purified water, sodium benzoate, sodium citrate, sucralose
Questions Or Comments?
1-877-958-8331 (Monday-Friday 9AM-5PM PST). You may also report serious side effects to this number.
Principal Display Panel - 40 Ml Bottle Label
●
PAIN
FAST
– LIQUID –
RELIEF®
FIRST AID
SHOT THERAPY®
BERRY
FDA
COMPLIANT
choline salicylate & caffeine
pain reliever
(NSAID)/pain reliever aid
1.35 FL OZ (40mL)
* Please review the disclaimer below.