Only For FEVER

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2020-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:51

Label at a glance#

ProductOnly For FEVER
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

Do not take more than directed. SEE OVERDOSE WARNING. adults and children 12 years of age and over  • take 2 caplets every 6 hours while symptoms last  • do not take more than 6 caplets in 24 hours, unless directed by doctor • do not take more than 10 days, unless directed by a doctor  children under 12 years of age  • ask a doctor

Storage and handling

• Store at room temperature between 20-25°C (68-77°F). • avoid excessive heat, cold and humidity. • close cap tightly after use.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain reliever / Fever reducer

Uses:

INDICATIONS & USAGE SECTION

• temporarily relieves minor aches and pains due to:

   • the common cold

   • backache

   • toothache

   • premenstrual and menstrual cramps

   • temporarily reduces fever.

   • headache

   • minor pain of arthritis

   • muscular aches

• temporarily reduces fever.

Warnings:

WARNINGS SECTION

Liver warning: 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

• 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 have ever had any allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver disease

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

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

• new symptoms occur.

• redness or swelling is present

These could be signs of a serious condition.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 of age and over

 • take 2 caplets every 6 hours while symptoms last

 • do not take more than 6 caplets in 24 hours, unless directed by doctor

• do not take more than 10 days, unless directed by a doctor

 children under 12 years of age • ask a doctor

Other Information:

STORAGE AND HANDLING SECTION

• Store at room temperature between 20-25°C (68-77°F).

• avoid excessive heat, cold and humidity.

• close cap tightly after use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-833-665-9444. (Mon-Fri 9am-5pm)

SPL UNCLASSIFIED SECTION

ADULT

PAIN RELIEVER FEVER REDUCER

TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing

Distributed By: O4 GLOBAL TRADING USA, LLC.

12222 Merit Drive, Suite 1900

Dallas, TX 75251-3209


www.onlyfor.com


Packaged By: Strive Pharmaceuticals Inc.

East Brunswick, NJ 08816.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73006-143-952023-01-30C16284748780-1f386c649-dc6b-0266-e053-dadaa90a7c1aOnly For ™ ​FEVER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-143-95Only For FEVER25 in 1 BOTTLE, PLASTICTABLET251
73006-143-95Only For FEVER1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-143ONLY FOR FEVER (ACETAMINOPHEN) TABLET [O4 GLOBAL TRADING USA, LLC]1Legacy NDC, 2 package rows20201224_f48585a4-2701-4fbd-a6e7-60fdd16244d9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-14373006-143-95

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1814e4c1-33b3-4015-bb78-206dba1401f5f48585a4-2701-4fbd-a6e7-60fdd16244d92020-11-19WarningsExact identifier
spl id: 1814e4c1-33b3-4015-bb78-206dba1401f5
spl set id: f48585a4-2701-4fbd-a6e7-60fdd16244d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.