Label: DEROFEN MIEL- guaifenesin .beta.-isomer syrup
- NDC Code(s): 81660-435-01
- Packager: Grimann, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 6, 2021
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- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
-
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. - INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
-
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. - PURPOSE
- ACTIVE INGREDIENT
- ACTIVE INGREDIENT
- FULL PACKAGE
-
INGREDIENTS AND APPEARANCE
DEROFEN MIEL
guaifenesin .beta.-isomer syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81660-435 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 11.8 g in 1 U Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 5.9 g in 1 U HONEY (UNII: Y9H1V576FH) 28.32 g in 1 U METHYLPARABEN (UNII: A2I8C7HI9T) 0.1 g in 1 U SUCROSE (UNII: C151H8M554) 53.1 g in 1 U PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.177 g in 1 U DEUDEXTROMETHORPHAN HYDROBROMIDE (UNII: W9F1OD5N5J) 0.236 g in 1 U ALCOHOL (UNII: 3K9958V90M) 0.481 mL in 1 U WATER (UNII: 059QF0KO0R) 118 mL in 1 U ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) 0.354 g in 1 U GUAIFENESIN .BETA.-ISOMER (UNII: 05T4JZ7JLV) 2.36 g in 1 U Product Characteristics Color red Score no score Shape Size 10mm Flavor RASPBERRY Imprint Code 118 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81660-435-01 1 U in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 05/05/2021 Labeler - Grimann, S.A. de C.V. (812806982) Registrant - Grimann, S.A. de C.V. (812806982) Establishment Name Address ID/FEI Business Operations GRIMANN, S.A. de C.V. 812806982 manufacture(81660-435) , label(81660-435)
