DOSAGE & ADMINISTRATION SECTION
DROG DOSAGE INSTRUCTIONS FOR ADMINISTRATION:
Adults and children 12 years and over: 1 tablet a day.
DROG DOSAGE INSTRUCTIONS FOR ADMINISTRATION:
Adults and children 12 years and over: 1 tablet a day.
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.
Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions
INACTIVE INGREDIENTES: Magnesium Stearate, Lactose
Starch Corn,Water
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
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.
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.
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
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81660-435-01 | DEROFEN MIEL | 1 U in 1 BOTTLE, GLASS | SYRUP | 1 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 81660-435 | 81660-435-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| HONEY | Y9H1V576FH | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | ACTIB |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| SUCROSE | C151H8M554 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| DEUDEXTROMETHORPHAN HYDROBROMIDE | W9F1OD5N5J | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| GUAIFENESIN .BETA.-ISOMER | 05T4JZ7JLV | IACT |
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 |
|---|---|---|---|---|---|---|
| bf4ea7e6-9d64-13e5-e053-2a95a90a5a1e | bc7ca2d2-0813-199e-e053-2a95a90a811a | 2021-04-06 | Warnings | bf4ea7e6-9d64-13e5-e053-2a95a90a5a1e bc7ca2d2-0813-199e-e053-2a95a90a811a |
Adverse event summaries are temporarily unavailable. Other product information remains available.