Label: FIRST AID SHOT THERAPY PAIN RELIEF- choline salicylate and caffeine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57815-081-01 - Packager: First Aid Beverages, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 21, 2015
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
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
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
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label
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INGREDIENTS AND APPEARANCE
FIRST AID SHOT THERAPY PAIN RELIEF
choline salicylate and caffeine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57815-081 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Choline Salicylate (UNII: KD510K1IQW) (Salicylic Acid - UNII:O414PZ4LPZ) Choline Salicylate 650 mg in 40 mL Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 65 mg in 40 mL Inactive Ingredients Ingredient Name Strength Anhydrous Citric Acid (UNII: XF417D3PSL) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Citrate (UNII: 1Q73Q2JULR) Sucralose (UNII: 96K6UQ3ZD4) Water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57815-081-01 40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/01/2015 Labeler - First Aid Beverages, Inc. (078618157)
