Muelsin by NARTEX LABORATORIOS HOMEOPATICOS SA DE CV

Muelsin by

Drug Labeling and Warnings

Muelsin by is a Homeopathic medication manufactured, distributed, or labeled by NARTEX LABORATORIOS HOMEOPATICOS SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MUELSIN- calcarea carbonica, chamomilla, coffea cruda liquid 
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Calcarea carbonica...................3 X HPUS

Chamomilla.............................3 X HPUS

Coffea cruda............................6 X HPUS

Calcarea carbonica...................3 X HPUS*...........................Supports dentition

Chamomilla.............................3 X HPUS*......................................Irritability

Coffea cruda............................6 X HPUS*..................................Resltessness

*The letters "HPUS" indicate that hte componenets in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.  "X" is an homeopathic dilution.  See www.nartexlabsusa.com for more information.  Active ingredients are prepared in accordance with teh Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Temporary relief from teething.

Product uses are based on Homeopathic Materia Medica.  These "Uses" have not been evlauated by the Food and Drug Administration.  This product has not been clinically tested by Nartex Labs USA, Inc.

Stop use and ask a physician if

  • symptoms persist for more than 7 days or if irritation persists
  • inflammation, fever or infection develops

Keep out of reach of children.  In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

  • wash hands
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small, pea-size amount of muelsin and spread over the gums
  • apply 2 drops on the sruface of the gums 3 to 4 times a day
  • for infants under 4 months of age, ask a physician or healthcare provider

  • do not use if tube tip is cut prior to opening

Anis flavor, glycerol, mint flavor, purified water, sodium benzoate

informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

QR Smartphone or login to

facebook/Nartex Labs

Product claims are based on Homeopathic Materia Medica.  This product has not been clinically tested by Nartex.

Keep carton.  It contains important information.

For you protection, this bottle has a seal around the neck.  Attention: do not use if the neck seal is broken.

This product is Homeopathic.  Its claims and efficacy are based on homeopathic research and clinical experience.  This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs.  For more information on homeopathy visit www.nartexlabsusa.com before using this product.

NDC: 34666-231-30

muelsin

Calcarea carbonica / Chamomilla / Coffea cruda

For Child teething pain relief*

drops

Homeopathic

Directions

Apply 2 drops on the sruface of the gums of 3 to 4 times a day ***

1.01 fl oz (30 mL)

*BASED ON HOMEOPATHIC MATERIA MEDICA

**SEE DIRECTIONS AT THE BACK

MuelsinCarton

MUELSIN 
calcarea carbonica, chamomilla, coffea cruda liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 34666-231
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE3 [hp_X]  in 30 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 30 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 30 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 34666-231-301 in 1 CARTON05/11/201612/26/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/11/201612/26/2019
Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
Registrant - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
Establishment
NameAddressID/FEIBusiness Operations
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV589914576manufacture(34666-231)

Revised: 12/2019
 
N

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.