Valumeds Aspirin Chewable

Valumeds Aspirin Chewable
SPL v2
SPL
SPL Set ID eb330933-be20-4c8e-a1aa-64c4f085c279
Route
ORAL
Published
Effective Date 2018-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Butylated Hydroxytoluene Dextrates Fd&c Yellow No. 6 Cellulose, Microcrystalline Modified Corn Starch (1-octenyl Succinic Anhydride) Orange Starch, Corn Sucralose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: UPPER;tcl334;LOWER;PLAIN Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-11

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Warnings and Precautions

Warnings

Purpose

Pain reliever

Description

Drug Facts

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever or other symptoms needing immediate relief.
  • ask your doctor about other uses for Aspirin 81 mg
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of 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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • gout
  • diabetes
  • 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 are taking a diuretic
  • you have asthma
Section 50570-1

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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: consult a doctor
Other Information
  • each tablet contains: sodium 0.22 mg
  • save carton for full directions and warnings
  • store at room temperature
Inactive Ingredients

BHT (Butylated Hydroxytoluene), dextrates, FD&C Yellow#6 Aluminum Lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sucralose, stearic acid

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel 36 Count Bottle Carton

VALUMEDS™

Compare to the active ingredient in

Bayer® Chewable Low Dose

Aspirin Regimen**

ASPIRIN CHEWABLE

ADULT LOW STRENGTH PAIN RELIEVER

ASPIRIN 81 mg (NSAID)*

36 TABLETS


Structured Label Content

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever or other symptoms needing immediate relief.
  • ask your doctor about other uses for Aspirin 81 mg
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of 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
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • gout
  • diabetes
  • 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 are taking a diuretic
  • you have asthma
Section 50570-1 (50570-1)

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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: consult a doctor
Other Information (Other information)
  • each tablet contains: sodium 0.22 mg
  • save carton for full directions and warnings
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

BHT (Butylated Hydroxytoluene), dextrates, FD&C Yellow#6 Aluminum Lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sucralose, stearic acid

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel 36 Count Bottle Carton (PRINCIPAL DISPLAY PANEL - 36 COUNT BOTTLE CARTON)

VALUMEDS™

Compare to the active ingredient in

Bayer® Chewable Low Dose

Aspirin Regimen**

ASPIRIN CHEWABLE

ADULT LOW STRENGTH PAIN RELIEVER

ASPIRIN 81 mg (NSAID)*

36 TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)