VALUMEDS EXTRA STRENGTH PAIN RELIEF

Set ID
72a8bc52-3864-4e3d-8659-eef2d959bdf9
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:42:00

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Uses

temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Warnings

WARNINGS SECTION

Warnings

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Directions And Dosage

Directions

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Other Label Information

Other information

each caplet contains: magnesium 0.43 mg store between 20-25°C (68-77°F)

Inactive ingredients

Hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle

VALUMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN 500 mg PAIN RELIVER/ FEVER REDUCER 100 CAPLETS

Products

NDC Codes

Ingredients

NameUNIIKind
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

WARNINGS SECTION

WARNINGS SECTION

Warnings

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

each caplet contains: magnesium 0.43 mg store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

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 - 500 mg Caplet Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN 500 mg PAIN RELIVER/ FEVER REDUCER 100 CAPLETS

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/72a8bc52-3864-4e3d-8659-eef2d959bdf9/28ecc17c-63b1-e58d-e063-6394a90afd3c.xml
XML SHA-256
bf9e522f01b5780398ac1b1f18f9d9e6acde560be93619c6dd130f5eaca854f6
XML bytes
27072

Legacy File Index

FolderFileDate
otc28ecc17c-63b1-e58d-e063-6394a90afd3c.xml2024-12-12
otc0c05e75e-4816-22e3-e063-6294a90a2a1e.xml2023-12-09
otceea02438-3b59-2899-e053-2995a90a7bdf.xml2022-11-30
otcd04ede6b-ba4e-828d-e053-2995a90abdc2.xml2021-11-09
otcb60c18e3-3816-2ecc-e053-2a95a90adeec.xml2020-12-10
otc9aaef15c-5cd8-7d33-e053-2a95a90a0bdb.xml2019-12-28
otc4f92a547-cfd9-4a66-e054-00144ff8d46c.xml2017-05-15
otcVM ES APAP Tablets 500 mg_201-01.jpg2017-05-15