DEROFEN MIEL- guaifenesin .beta.-isomer syrup 
Grimann, S.A. de C.V.

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.

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DEROFEN MIEL.

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.

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

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FULL PACKAGE

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DEROFEN MIEL 
guaifenesin .beta.-isomer syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81660-435
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL11.8 g  in 1 U
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeSize10mm
FlavorRASPBERRYImprint Code 118
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81660-435-011 U in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/05/2021
Labeler - Grimann, S.A. de C.V. (812806982)
Registrant - Grimann, S.A. de C.V. (812806982)
Establishment
NameAddressID/FEIBusiness Operations
GRIMANN, S.A. de C.V.812806982manufacture(81660-435) , label(81660-435)

Revised: 4/2021
Document Id: bf4ea7e6-9d64-13e5-e053-2a95a90a5a1e
Set id: bc7ca2d2-0813-199e-e053-2a95a90a811a
Version: 5
Effective Time: 20210406
 
Grimann, S.A. de C.V.