FDA Label for Natural Aspirin Plus Immune Supporting Dietary Supplement
View Indications, Usage & Precautions
Natural Aspirin Plus Immune Supporting Dietary Supplement Product Label
The following document was submitted to the FDA by the labeler of this product Applied Biological Laboratories 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.
Active Ingredient
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever and fever reducer
Uses
For temporary relief of minor aches and pain associated with chills, headache, body aches, fever, and sore throat.
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.
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 a longer time than directed.
Otc - Do Not Use
Do not use if allergic to milk, egg, wintergreen oil, and/or menthol, or have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
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 have asthma, you are taking a diuretic.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation, diabetes, gout or arthritis.
Otc - Stop Use
Stop use and ask a doctor if: an allergic reaction occurs. Seek medical help right away. • 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 • redness or swelling is present • new symptoms occur • ringing in the ears or a loss or hearing occurs
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 specifically 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 accidental 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 over: Take 1 to 2 tablets every 4 hours while symptoms last
- Do not take more than 12 tablets in 24 hours unless directed by a doctor
- Children under 12 years: do not use unless directed by a doctor
Inactive Ingredients
Bamboo extract, calcium carbonate, coconut oil, dicalcium phosphate, maize starch, pectin, sodium alginate, stearic acid, sugar, sunflower lecithin
Other
biovanta ®
(NSAID*) Non-Drowsy | Sugar Free
MULTI-SYMPTOM RELIEF COLD
FOR PAIN RELIEF ASSOCIATED WITH: Chills, Headache, Fever, and Sore Throat
TAKE TABLET
1. Take Tablet to Treat Symptoms
4 TABLETS
Questions or Comments?
866-889-3959
Distributed by:
Applied Biological Laboratories
760 Parkside Ave., 317
Brooklyn, New York 11226
IMMUNE-SUPPORTING* SPRAY
USE SPRAY
DIETARY SUPPLEMENT
2. Use Spray to Help Support Immunity
Net Wt. 10 mL (.338 fl oz)
* Please review the disclaimer below.