Acetaminophen 500mg Diphenhydramine HCl 25mg

Manufacturer
Strive Pharmaceuticals Inc
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:33:43

Label at a glance#

ProductAcetaminophen 500mg Diphenhydramine HCl 25mg
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg; Diphenhydramine 25mg

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

  • take with a full glass of water
  • do not take more than directed
  • do not take more than 2 caplets in 24 hours
adults and children 12 years of age and over
  • 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
children under 12 years of agedo not use

INDICATIONS & USAGE SECTION

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

WARNINGS SECTION

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000mg 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 non prescription). 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 youhave 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 prostrate gland
  • glaucoma

Ask a doctor or a pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoi 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 lasts 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

Keep out of reach of children

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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.

OTC - PURPOSE SECTION

Pain reliever

Nighttime sleep-aid

OTHER SAFETY INFORMATION

  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB11905LB11905CT11905CT11905CT11941CT11941

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD3
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY3

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-119-05Acetaminophen 500mg Diphenhydramine HCl 25mg50 in 1 PACKAGETABLET503
70692-119-41Acetaminophen 500mg Diphenhydramine HCl 25mg4 in 1 PACKAGETABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-119ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG TABLET [STRIVE PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20201117_9238598b-1202-921f-e053-2995a90a019f.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
70692-11970692-119-41, 70692-119-05

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
b43d776e-b5f4-16b9-e053-2995a90a66b99238598b-1202-921f-e053-2995a90a019f2020-11-16WarningsExact identifier
spl id: b43d776e-b5f4-16b9-e053-2995a90a66b9
spl set id: 9238598b-1202-921f-e053-2995a90a019f

Reported adverse events (FAERS/openFDA)#

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