DEROFEN MIEL- guaifenesin .beta.-isomer syrup

DEROFEN MIEL by

Drug Labeling and Warnings

DEROFEN MIEL by is a Otc medication manufactured, distributed, or labeled by Grimann, S.A. de C.V., GRIMANN, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

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

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

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.

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

ACTIVE INGREDIENT

ACTIVE INGREDIENT

FULL PACKAGE

INGREDIENTS AND APPEARANCE

DEROFEN MIEL 
guaifenesin .beta.-isomer syrup

Product 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)