Biovanta New & Improved Convenience Kit: Natural Aspirin Tablet + Immune Supporting Dietary Supplement Throat Spray

Biovanta New & Improved Convenience Kit: Natural Aspirin Tablet + Immune Supporting Dietary Supplement Throat Spray
SPL v1
SPL
SPL Set ID fa6a56cb-b623-d17a-e053-6394a90a9694
Route
ORAL
Published
Effective Date 2023-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Anhydrous Starch, Corn Pectin Sucrose Stearic Acid Lecithin, Sunflower Calcium Carbonate Coconut Oil Bambusa Vulgaris Top Sodium Alginate

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 9 mm
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-04-25

Description

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever and fever reducer


Medication Information

Purpose

Pain reliever and fever reducer

Description

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

For temporary relief of minor aches and pain associated with chills, headache, body aches, fever, and sore throat.

Section 42229-5

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

[email protected]

Distributed by:

Applied Biological Laboratories

760 Parkside Ave., 317

Brooklyn, New York 11226

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation, diabetes, gout or arthritis.

Section 50569-3

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.

Section 50570-1

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.

Section 51945-4

Section 53414-9

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.

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.

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
Active Ingredient

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

Bamboo extract, calcium carbonate, coconut oil, dicalcium phosphate, maize starch, pectin, sodium alginate, stearic acid, sugar, sunflower lecithin


Structured Label Content

Uses

For temporary relief of minor aches and pain associated with chills, headache, body aches, fever, and sore throat.

Section 42229-5 (42229-5)

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

[email protected]

Distributed by:

Applied Biological Laboratories

760 Parkside Ave., 317

Brooklyn, New York 11226

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation, diabetes, gout or arthritis.

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

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.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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.

Purpose

Pain reliever and fever reducer

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.

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
Active Ingredient (Active ingredient)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

Bamboo extract, calcium carbonate, coconut oil, dicalcium phosphate, maize starch, pectin, sodium alginate, stearic acid, sugar, sunflower lecithin


Advanced Ingredient Data


Raw Label Data

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