VALUMEDS ASPIRIN

Set ID
f77078a8-3268-41f8-ba89-29386a1ad281
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:41:46

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

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

Purpose

Pain reliever

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

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

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 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

Directions And Dosage

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 Label Information

Other information

each tablet contains: sodium 0.36 mg store at room temperature

Inactive ingredients

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 100 Tablets Bottle

VALUMEDS ASPIRIN ADULT LOW STRENGTH PAIN RELIEVER ASPIRIN 81 mg (NSAID)* 100 TABLETS ENTERIC SAFETY COATED

Products

NDC Codes

Ingredients

NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM HYDROXIDE55X04QC32IIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
ASPIRINR16CO5Y76EACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS SECTION

Warnings

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause 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 SECTION

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction occurs. Seek medical 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

each tablet contains: sodium 0.36 mg store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL - 100 Tablets Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS ASPIRIN ADULT LOW STRENGTH PAIN RELIEVER ASPIRIN 81 mg (NSAID)* 100 TABLETS ENTERIC SAFETY COATED

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

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Legacy File Index

FolderFileDate
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otc0c05b1cc-f9eb-1af0-e063-6294a90aea2b.xml2023-12-09
otceea02ad9-ae9c-4741-e053-2995a90add76.xml2022-11-30
otcd04e7255-b61c-281b-e053-2995a90aef5c.xml2021-11-09
otcb60c0f42-635f-7439-e053-2995a90a564e.xml2020-12-10
otc69999b34-b058-9d85-e053-2a91aa0a42ce.xml2018-04-12
otcVM Aspirin 81mg Tablets 100ct_981-01.jpg2018-04-12