Gastrolean by NARTEX LABORATORIOS HOMEOPATICOS SA DE CV / LABORATORIOS HOMEOPATICOS SA DE CV

Gastrolean by

Drug Labeling and Warnings

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

Drug Details [pdf]

GASTROLEAN- magnesia carbonica, natrum sulphuricum, nux vomica, robinia pseudoacacia pellet 
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.

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Magnesia carbonica 8x, Natrum sulphuricum 8x, Nux vomica 4x, Robinia pseudoacacia 4x

Magnesia carbonica...............................Antispasmodic

Natrum sulphuricum......................Antacid, Antiflatulent

Nux vomica...............................................Antiflatulent

Robinia pseudoacacia......................................Antacid

Temporarily relives symptoms caused by indigestion and sour stomach such as:

• heartburn
• intestinal spasms
• belching
• acid risings
• bloating
• gas
• as per homeopathic materia medica
  

Do Not

• take more than 26 pellets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician
• use if you have an allergy or hypersensitivity to the components of the formula

Keep box

as it contains important information.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug.

Stop use and ask a doctor if

• condition worsens
  
• rash develops
• if symptoms persist for more than 4 days or clear up and occur again within a few days
  

If pregnant or breast feeding, consult a health professional before use.

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

Directions

• adults and children 6 years of age and older:  take 3 pellets orally every 15 minutes for two hours.  Then take 3 pellets before each meal
• dissolve slowly in mouth
• children under 6 years of age: consult a physician
  

store in a cool and dry place

Sucrose

Questions or comments?

informacion@nartexlabs.com or call 1-800-839-0916 between 9am and 5pm CST

GASTROLEAN 
magnesia carbonica, natrum sulphuricum, nux vomica, robinia pseudoacacia pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-081
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROBINIA PSEUDOACACIA BARK (UNII: 7TPC058OWY) (ROBINIA PSEUDOACACIA BARK - UNII:7TPC058OWY)	ROBINIA PSEUDOACACIA BARK	4 [hp_X]
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	8 [hp_X]
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFATE	8 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	4 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-081-50	150 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/25/2011	12/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/25/2011	12/26/2019

Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)

Registrant - LABORATORIOS HOMEOPATICOS SA DE CV (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS HOMEOPATICOS SA DE CV		589914576	manufacture(34666-081)

Revised: 12/2019

Document Id: 9aa3e8d9-26fe-1b33-e053-2a95a90abfd0

34390-5

Set id: d0b40fc1-47cd-4b2a-8228-a6af8707e822

Version: 3

Effective Time: 20191226

 

NARTEX LABORATORIOS HOMEOPATICOS SA DE CV