Defensol-ito solution

Manufacturer: Menper Distributors, Inc | RNV, LLC
Effective date: 2025-07-22
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:08:20

Label at a glance#

ProductDefensol-ito

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Contacts and useful links#

PhoneLabel contact1-800-560-5223

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 1 mL, dropperful) Purpose

Dextromethorphan 4 mg............................................................................Cough Suppressant

Guiafenesin 50 mg............................................................................Expectorant

Phenylephrine HCl 2.5mg...................................................................Nasal Decongestant

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses temporarily relives these symptoms occuring with cold:

nasal congestion
cough due to minor throat and bronchial irriatation
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

WARNINGS SECTION

Do not use in child who is 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 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.

Ask a doctor before use if your child has

heart disease
thyroid disease
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with asthma
high blood pressure
diabetes

When using this product, do not use more than directed

Stop use and ask doctor if

your child gets nervous, dizzy, or sleepless
symptoms do not get better within 7 days, comes back, or is accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could b signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep ot of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

do not use more than doses in any 24-hour period
repeat every 4 hours
choose dosage by weight (if weight is not known, choose by age)
measure with the dosing device provided. Do not use with any other device.

Age Weight Dose

2 to under 6 years 24-47 Lbs 1 mL

under 2 years under 24 Lbs ask as doctor

OTC - QUESTIONS SECTION

Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

INACTIVE INGREDIENT SECTION

Inactive ingradients

citric acid, corn syrup, FD&C yellow #6, flavor, glycerin, guar gum,menthol, methylparaben, propylene glycol, propylparaben, sodium saccharin, sucralose, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Defensol-ito Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1661314	dextromethorphan HBr 4 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution	PSN	8
1661314	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution	SCD	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-333-15	2023-07-28	C162847	48780-1	9d75b9d0-fdb7-f424-e053-dadaa90a57ce	Defensol-ito solution
53145-333-15	2021-08-09	C162847	48780-1	9d75b9d0-fdb7-f424-e053-dadaa90a57ce	Defensol-ito solution
53145-333-15	2020-01-31	C162847	48780-1	9d75b9d0-fdb7-f424-e053-dadaa90a57ce	Defensol-ito solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-333-15	Defensol-ito	30 mL in 1 BOTTLE, DROPPER	SOLUTION	30		8
53145-333-15	Defensol-ito	1 in 1 CARTON	SOLUTION	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	5
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	5
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	5
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	5
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	5
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	5
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	5
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	5
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	5
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	5

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Defensol-ito
Dextromethorphan, Guiafenesin, Phenylephrine
CORN SYRUP
FD&C YELLOW NO. 6
GLYCERIN
GUAR GUM
MENTHOL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
CITRIC ACID MONOHYDRATE
SACCHARIN SODIUM
SUCRALOSE
WATER
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53145-333	53145-333-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CORN SYRUP	9G5L16BK6N	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GLYCERIN	PDC6A3C0OX	IACT
GUAR GUM	E89I1637KE	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
WATER	059QF0KO0R	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	CAPSULE / ORAL	3.3 mg		Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	POWDER, FOR SUSPENSION / ORAL		100 mg	Exact identifier — unii+route 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / ORAL	4.93 mg/5ml		Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		36 mg	Exact identifier — unii+route 20 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		36 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	CAPSULE / ORAL	3.3 mg		Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	LIQUID / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET / ORAL		240 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii+route 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET / ORAL		240 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	POWDER, FOR SUSPENSION / ORAL		100 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SOLUTION / ORAL	750 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / ORAL	4.93 mg/5ml		Exact identifier — unii+route 20 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	LIQUID / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SOLUTION / ORAL	750 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Defensol-ito	DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE	Menper Distributors, Inc	a7c7a60d-d49f-4239-92f7-714eac7eb0c5	2025-07-22	Warnings	Exact identifier ndc (package): 53145-333-15 ndc (product): 53145-333 ndc11 (package): 53145033315 spl id: 3a8ae61d-30c1-903c-e063-6394a90ae5c2 spl set id: a7c7a60d-d49f-4239-92f7-714eac7eb0c5

Reported adverse events (FAERS/openFDA)#

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