Defensol D Blister Pack

Manufacturer
Menper Distributors, Inc. | LNK International, Inc
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:12

Label at a glance#

ProductDefensol D Blister Pack
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCI 5 mg

OTC - PURPOSE SECTION

Purpose

Pain Reliever

Antihistamine/ Cough Suppresant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves these symptoms associated with cold or flu:

  • headache
  • nasal congestion
  • sore throat
  • fever
  • minor aches and pains
  • Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • nasal congestion
  • itching of the nose or throat
  • itchy, watery eyes

Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

WARNINGS SECTION

Warnings

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

  • more than 8 tablets in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Severe throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

OTC - DO NOT USE SECTION

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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after
stopping the MADI drug. If you do not know if your prescription drug contains MADI, ask a doctor or
pharmacist befaretakingthisprocluct.
■ if you have ever had an allergic reaction to this product or any of its ingredients
■ to sedate a child or to make a child sleepy
■ with any other product containing diphenhydramine, even one used on skin.

OTC - ASK DOCTOR SECTION

Ask doctor before use if you have

  • liver desease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema, asthma, or chronic bronchitis
  • taking the blood thinning drug warfarin
  • taking any other oral nasal decongestant or stimulant
  • taking any other pain relieve/fever reducer
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur in children

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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

Keep out of reach of children.

OVERDOSAGE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions: do not take more than 12 tablets in a 24 hour period.

  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. This adult product is not intended for use in children under 12 years of age
age dose
adults and children 12 years and over 2 tablets every 4 hours
children under 12 years do not use

INACTIVE INGREDIENT SECTION

Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C blue#1 aluminum lake, FO&C blue#2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid, and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, s I con dioxide, sodium bicarbonate, stearic acid, talc, titanium oxide.

OTC - QUESTIONS SECTION

Questions?Menper Distributors, Inc. 1-800-560-5223; M-F 9 AM - 4 PM Eastern

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackPack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1233575acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1233575acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1233575acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletSY2
1233575APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-009-30Defensol D Blister Pack1 in 1 BOXTABLET12
53145-009-30Defensol D Blister Pack30 in 1 BLISTER PACKTABLET302

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-00953145-009-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
ndc (package): 53145-009-30
ndc (product): 53145-009
ndc11 (package): 53145000930
spl id: 3a893b13-e7eb-c5b1-e063-6394a90a4253
spl set id: 0dfcc977-6101-4536-e063-6294a90a7a48

Reported adverse events (FAERS/openFDA)#

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