Only For BODY PAIN

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 BODY PAIN
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

•  temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

• take with a full glass of water • Do not take more than directed. SEE OVERDOSE WARNING. • do not take more than 2 caplets in 24 hours adults and children 12 years of age and over  • take 2 caplets at bedtime  • do not take more than 2 caplets of this product in 24 hours  children under 12 years of age  • do not use

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

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Nighttime sleep aid

Uses:

INDICATIONS & USAGE SECTION

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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.

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

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

Ask a doctor before use if you have

• liver disease

• a breathing problem such as emphysema or chronic bronchitis

• trouble urinating due to an enlarged prostate gland

• glaucoma.

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

• taking sedatives or tranquilizers.

When using this product

• drowsiness will occur

• avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery.

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

• redness or swelling is present

• new symptoms occur.

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 WARNINGS: 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.

• do not take more than 2 caplets in 24 hours

adults and children 12 years of age and over

 • take 2 caplets at bedtime

 • do not take more than 2 caplets of this product in 24 hours

 children under 12 years of age • do not use

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

colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

ADULT

PAIN RELIEVER NIGHTTIME SLEEP AID

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
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD1
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73006-120-952022-07-29C16284748780-1e4f33bdf-b288-d8a0-e053-dadaa90a6e4eOnly For ™ ​BODY PAIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-120-95Only For BODY PAIN1 in 1 CARTONTABLET11
73006-120-95Only For BODY PAIN25 in 1 BOTTLE, PLASTICTABLET251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-120ONLY FOR BODY PAIN (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [O4 GLOBAL TRADING USA, LLC]1Legacy NDC, 2 package rows20201224_ff61406a-ca7c-4b8d-a730-8bdbceab0389.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-12073006-120-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
ec528ea0-2522-4f3b-87dd-0fd9efa639f2ff61406a-ca7c-4b8d-a730-8bdbceab03892020-11-19WarningsExact identifier
spl id: ec528ea0-2522-4f3b-87dd-0fd9efa639f2
spl set id: ff61406a-ca7c-4b8d-a730-8bdbceab0389

Reported adverse events (FAERS/openFDA)#

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