FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Package Label.Principal Display Panel
Otc - Active Ingredient
Acetyl Salicylic Acid (NSAID) 6mg
nonsteroidal anti-inflammatory drug
For the temporary relief of minor aches and pains associated with a sore throat.
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:
- facial swelling
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- takes more or for a longer time than directed
- is age 60 or older
- has 3 or more alcoholic drinks every day while using this product
If pregnant or breast-feeding, always ask your healthcare provider before use.
Do Not Use
Do not use:
- if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems, unless directed by a doctor
- If allergic to milk and/or egg white, or have ever had an allergic reaction to this product or any of its ingredients.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult your healthcare provider.
Keep Out Of Reach Of Children
Children Warning: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Apply one spray of Step1 and one spray of Step2 to the affected area every thirty minutes or as needed.
- Allow to remain in place for at least 15 seconds.
- Once mixed, do not use after 90 days.
■ Store at room temperature.
■ Check unmixed product expiration date. Once mixed, fill in activation date on spray label watermark area. Do not use after 90 days after activation.
Tamper Evident: Do not use if imprinted shrink band is broken or missing.
Aloe, Ethanol, Glycerin, Lactoferrin, Lysozyme, Menthol, Propylene Glycol, Sodium Chloride, Sorbic Acid, Water
* Please review the disclaimer below.