Dosage & Administration
DROG DOSAGE INSTRUCTIONS FOR ADMINISTRATION:
Adults and children 12 years and over: 1 tablet a day.
Derofen Miel
FDA Label NDC 81660-435
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grimann, S.a. De C.v. for the product Derofen Miel (NDC 81660-435). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, warnings and precautions, translation and correction, inactive ingredient, indications & usage, otc - keep out of reach of children, warnings, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings And Precautions
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
Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions
Inactive Ingredient
INACTIVE INGREDIENTES: Magnesium Stearate, Lactose
Starch Corn,Water
Indications & Usage
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
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.
Warnings
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
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
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