Only For

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2019-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:28

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   • headache   • backache   • minor pain of arthritis   • toothache   • muscular aches   • premenstrual and menstrual cramps   • temporarily reduces fever 

Dosage and administration

take with a full glass of water d o not take more than directed (See Overdose Warning)  adults and children 12 years of age & over  • take 2 caplets every 6 hours while symptoms persist.  • 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 of age  ask a doctor

Storage and handling

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

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   • headache   • backache   • minor pain of arthritis   • toothache   • muscular aches   • premenstrual and menstrual cramps   • temporarily reduces fever 

Warnings:

WARNINGS SECTION

Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 3,000mg of acetaminophen in 24 hours, which is the maximum daily amount
• 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 are allergic to acetaminophen or any of the inactive ingredients in this product
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have
liver disease

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

Stop use and ask a doctor if
• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose Warning: In case of accidental 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

  • take with a full glass of water
  • do not take more than directed (See Overdose Warning)
 adults and children 12 years of age & over

 • take 2 caplets every 6 hours while symptoms persist.

 • 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 of age ask a doctor

Other Information:

STORAGE AND HANDLING SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, gelatin, glycerin, hydroxypropyl methyl cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycolate.

Questions Or Comments ?

OTC - QUESTIONS SECTION

1-833-665-9444.

SPL UNCLASSIFIED SECTION

NDC: 73006-117-41

ADULT

PAIN RELIEVER-FEVER REDUCER

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.
www.onlyfor.com
Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OnlyForOnlyFor

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
73006-117-412022-01-28C16284748780-1d6a99b39-9e9a-a426-e053-dadaa90af4c2Only For- FEVER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-117-41Only ForFEVER4 in 1 BLISTER PACKTABLET41
73006-117-41Only ForFEVER1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-117ONLY FOR FEVER (ACETAMINOPHEN) TABLET [O4 GLOBAL TRADING USA, LLC ]1Legacy NDC, 2 package rows20190515_8e329277-1dad-423d-bec6-87cf4e82dee0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-11773006-117-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
9bae1988-d7bb-4541-891b-009296e605ae8e329277-1dad-423d-bec6-87cf4e82dee02019-05-09WarningsExact identifier
spl id: 9bae1988-d7bb-4541-891b-009296e605ae
spl set id: 8e329277-1dad-423d-bec6-87cf4e82dee0

Reported adverse events (FAERS/openFDA)#

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