Defensolito
- Manufacturer
- Menper Distributors, Inc. | Lex Pharma
- Effective date
- 2025-07-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:08:13
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet)
Acetaminophen 80 mg
Phenylephrine Hydrochloride 2.5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/ Fever Reducer
Nasal Decongestant
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves
- nasal decongestion due to a common cold, hay fever or other upper respiratory allergies, nasal stuffiness, sinus congestion and pressure
- minor aches and pains associated with the common cold, sore throat, headache, tootheache and flu
WARNINGS SECTION
Warnings
Do not exceed recommended dosage. Do not give to children under 6 years of age.
Liver toxicity may occur if
- recommended dosage is exceeded
- used with other products containing acetaminophen
- used with moderate amounts of alcohol
Drug Interaction Precaution: Do not use in a child who is taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or Parkinson's Disease), or for two weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
OTC - DO NOT USE SECTION
Do not give this product to a child unless directed by a doctor:
- with any other products containing acetaminophen (prescription or non-prescription)
- if you are not sure whether a drug contains acetaminophen
- if your child is allergic to acetaminophen or any other ingredients in the product
- for more than 5 days for pain
- for more than 3 days for fever
- who has heart disease, high blood pressure, thyroid disease, or diabetes
- who is taking blood thinning drug warfarin
- if your child has liver disease
OTC - STOP USE SECTION
Stop use and ask doctor promptly if
- pain persists and gets worse, if new symptoms occur or if redness or swelling is present because these could be signs of a serious condition
- symptoms do not improve or are accompanied by a fever
- if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting
- nervousness, dizziness, or sleeplessness occur
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding,ask a health care professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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 children even if you do not notice any signs or symptoms
DOSAGE & ADMINISTRATION SECTION
Directions
- Do not take more than 6 doses (12 chewable tablets) in a 24 hour period
| Children 6 to under 12 years of age | take 2 chewable tablets every 4 hours |
| Children under 6 years of age | consult a doctor |
INACTIVE INGREDIENT SECTION
Inactive IngredientsAspartame, Carboxymethylcellulose Sodium, FD&C #40 aluminum lake, Flavor, Lactose, Magnesium Stearate, Polyvinyl Pirrolidone, Silicon Dioxide, Starch, Sugar and Talc.
OTC - QUESTIONS SECTION
Questions?Call 1-800-560-5223 weekdays 9 AM-4 PM EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-006-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-602e-f424-e053-dadaa90a57ce | Defensol-ito |
| 53145-006-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-602e-f424-e053-dadaa90a57ce | Defensol-ito |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-006-02 | Defensolito | 50 in 1 CARTON | TABLET, CHEWABLE | 50 | 4 | |
| 53145-006-02 | Defensolito | 2 in 1 PACKET | TABLET, CHEWABLE | 2 | 4 | |
| 53145-006-30 | Defensolito | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 4 | |
| 53145-006-30 | Defensolito | 1 in 1 BOX | TABLET, CHEWABLE | 1 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYVINYL ACETATE PHTHALATE | INACTIVE INGREDIENT | 58QVG85GW3 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| SUGARCANE | INACTIVE INGREDIENT | 81H2R5AOH3 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 |
Products#
Every source-derived product name is available through these pages.
- Defensolito
- Acetaminophen, Phenylephrine Hydrochloride
- ASPARTAME
- CARBOXYMETHYLCELLULOSE SODIUM
- LACTOSE
- MAGNESIUM STEARATE
- POLYVINYL ACETATE PHTHALATE
- SILICON DIOXIDE
- STARCH, CORN
- SUGARCANE
- TALC
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53145-006 | 53145-006-02, 53145-006-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPARTAME | Z0H242BBR1 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SUGARCANE | 81H2R5AOH3 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | FILM / BUCCAL | 18 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYRUP / ORAL | 26.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| POLYVINYL ACETATE PHTHALATE | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | CAPSULE, EXTENDED RELEASE / ORAL | 32 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION / INTRA-ARTICULAR | 25 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 25 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SYRUP / ORAL | 0.63 mg/5ml | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SOLUTION / RECTAL | 8 %w/v | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| POLYVINYL ACETATE PHTHALATE | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | CAPSULE / ORAL | 48 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | CAPSULE / ORAL | 160 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET / SUBLINGUAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| POLYVINYL ACETATE PHTHALATE | POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | TABLET, EXTENDED RELEASE / ORAL | 110 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAMUSCULAR | 203.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, COATED / ORAL | 332.05 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRA-ARTICULAR | 30 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, SUGAR COATED / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CREAM / VAGINAL | 3 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3a875ad3-8a76-b446-e063-6294a90a1a63 | 2a3f498d-445f-410b-818f-9f119bd6c492 | 2025-07-22 | Warnings | 3a875ad3-8a76-b446-e063-6294a90a1a63 2a3f498d-445f-410b-818f-9f119bd6c492 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
