biovanta new & improved convenience kit: natural aspirin tablet + lemon & honey lozenge dietary supplement

biovanta new & improved convenience kit: natural aspirin tablet + lemon & honey lozenge dietary supplement
SPL v1
SPL
SPL Set ID fa45141d-ac32-ca9b-e053-6394a90a5cbb
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

Purpose

Pain reliever and fever reducer

Description

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


Medication Information

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.

Uses

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

Purpose

Pain reliever and fever reducer

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

Description

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

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.

Active Ingredient

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

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.

Uses

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

Purpose

Pain reliever and fever reducer

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 (Inactive ingredients)

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

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.

Active Ingredient (Active ingredient)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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