DEROFEN MIEL

Manufacturer
Grimann, S.A. de C.V.
Effective date
2021-04-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:42:19

Label at a glance#

ProductDEROFEN MIEL
Active ingredientPROPYLENE GLYCOL
Label structure10 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DROG DOSAGE INSTRUCTIONS FOR ADMINISTRATION:
Adults and children 12 years and over: 1 tablet a day.

WARNINGS AND PRECAUTIONS SECTION

WARNINGS AND PRECAUTIONS: Do not exceed the recommended
dosage. If you are taking other medicines, consult your doctor.
Do not use loratadine with alcohol or other central nervous
system depressants. Children under 12 years old: do not use
PEDIATRIC USE: Children under 12 years of age: do not use.
PREGNANCY AND BREASTFEEDING: Do not use during pregnancy
or breastfeeding.
CONTRAINDICATIONS: Do not use in case of hypersensitivity to
the ingredients.
ADVERSE REACTIONS: Fatigue, headache, dry mouth, nausea,
gastritis, skin rash.
ACCIDENTAL INGESTION AND OVERDOSE: Reported symptoms in
case of overdose: sleepiness, tachycardia, headache.
The treatment that should be started immediately is symptomatic
and adjuvant. Keep out of reach of children. If symptoms persist
for more than 5 days, consult your doctor.
Do not store above 86°F. Keep this container tightly closed.

TRANSLATION And Correction

RECENT MAJOR CHANGES SECTION

Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTES: Magnesium Stearate, Lactose
Starch Corn,Water

INDICATIONS & USAGE SECTION


Therapeutic indications: Indicated for the symptomatic
treatment of manifestations related to allergic rhinitis
such as:
sneezing, runny nose and watery eyes.
Also indicated for chronic hives and other manifestations
of allergic dermatological disorder

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

WARNINGS AND PRECAUTIONS: Do not exceed the recommended
dosage. If you are taking other medicines, consult your doctor.
Do not use loratadine with alcohol or other central nervous
system depressants. Children under 12 years old: do not use
PEDIATRIC USE: Children under 12 years of age: do not use.
PREGNANCY AND BREASTFEEDING: Do not use during pregnancy
or breastfeeding.
CONTRAINDICATIONS: Do not use in case of hypersensitivity to
the ingredients.
ADVERSE REACTIONS: Fatigue, headache, dry mouth, nausea,
gastritis, skin rash.
ACCIDENTAL INGESTION AND OVERDOSE: Reported symptoms in
case of overdose: sleepiness, tachycardia, headache.
The treatment that should be started immediately is symptomatic
and adjuvant. Keep out of reach of children. If symptoms persist
for more than 5 days, consult your doctor.
Do not store above 86°F. Keep this container tightly closed.

OTC - PURPOSE SECTION

PURPOUSE/ USES
Indicated for the symptomatic treatment of
manifestations related to allergic rhinitis such as:
▪ runny nose
▪ sneezing
▪ itchy, watery eyes
▪ itching of the nose or throat

OTC - ACTIVE INGREDIENT SECTION

22222222222222

FULL PACKAGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81660-435-01DEROFEN MIEL1 U in 1 BOTTLE, GLASSSYRUP15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81660-435DEROFEN MIEL (GUAIFENESIN .BETA.-ISOMER) SYRUP [GRIMANN, S.A. DE C.V.]5Legacy NDC, 1 package rows20210909_bc7ca2d2-0813-199e-e053-2a95a90a811a.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81660-43581660-435-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
bf4ea7e6-9d64-13e5-e053-2a95a90a5a1ebc7ca2d2-0813-199e-e053-2a95a90a811a2021-04-06WarningsExact identifier
spl id: bf4ea7e6-9d64-13e5-e053-2a95a90a5a1e
spl set id: bc7ca2d2-0813-199e-e053-2a95a90a811a

Reported adverse events (FAERS/openFDA)#

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