bio formula aspirin 81mg

bio formula aspirin 81mg
SPL v6
SPL
SPL Set ID 5910a882-eb40-440f-8a30-c21fbce9050e
Route
oral
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (81 mg)
Inactive Ingredients
anhydrous lactose carnauba wax silicon dioxide croscarmellose sodium d&c yellow no. 10 ferric oxide yellow cellulose, microcrystalline polysorbate 80 dimethicone sodium hydroxide sodium lauryl sulfate talc titanium dioxide triethyl citrate methacrylic acid

Identifiers & Packaging

Pill Appearance
Imprint: A Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
otc monograph drug active Since 2014-12-18

Purpose

Pain reliever

Description

Aspirin 81mg (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 non presecription 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 the temporary relief of minor aches and pain or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Purpose

Pain reliever

Directions
  • drink a full glass of water with each dose  
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor 
  • children under 12 years of age: consult a doctor
Other Information
  • save carton for full directions and warnings
  • store at room temperature
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

anhydrous lactose, carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Description

Aspirin 81mg (NSAID)* *nonsteroidal anti-inflammatory drug

Principal Display Panel

Bio Formula

ASPIRIN

(NSAID*)

81mg SAFETY COATED

ENTERIC COATED

LOW STRENGTH ASPIRIN REGIMEN

DELAYED RELEASE ASPIRIN

Bio Formula Aspirin 81mg Carton 100ct
Bio Formula Aspirin 81mg Label 100ct
Bio Formula Aspirin 81mg Label 300ct
Do Not Use

if you are allergic to aspirin or other pain reliever/fever reducer

Active Ingredient

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pregnancy/breastfeeding

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.

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

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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report serious side effects to 1-888-952-0050

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If
  • you are taking a prescription drug for
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis


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 non presecription 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 the temporary relief of minor aches and pain or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Purpose

Pain reliever

Directions
  • drink a full glass of water with each dose  
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor 
  • children under 12 years of age: consult a doctor
Other Information (Other information)
  • save carton for full directions and warnings
  • store at room temperature
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

anhydrous lactose, carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Principal Display Panel

Bio Formula

ASPIRIN

(NSAID*)

81mg SAFETY COATED

ENTERIC COATED

LOW STRENGTH ASPIRIN REGIMEN

DELAYED RELEASE ASPIRIN

Bio Formula Aspirin 81mg Carton 100ct
Bio Formula Aspirin 81mg Label 100ct
Bio Formula Aspirin 81mg Label 300ct
Do Not Use (Do not use)

if you are allergic to aspirin or other pain reliever/fever reducer

Active Ingredient (Active ingredient)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

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.

Ask A Doctor Before Use If (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

Stop Use and Ask A Doctor If (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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • You may report serious side effects to 1-888-952-0050

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • you are taking a prescription drug for
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis


Advanced Ingredient Data


Raw Label Data

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