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ORGAN-I NR by Rebel Distributors Corp

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-048

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.

ORGAN-I NR

Active ingredient

Guaifenesin, USP 200 mg

Purpose

Expectorant

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have
  • cough that occurs with too much phlegm (mucus)  
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask 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
  • do not take more than 6 doses in any 24-hour period  
  • this adult product is not intended for use in children under 12 years of age
adults and children
12 years and over 
1 - 2 tablets
every 4 hours 
children under
12 years 
do not use 

Other information
  • store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

D&C red #30 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinylpyrrolidine, pregelatinized starch, silicon dioxide, stearic acid

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 3/11 R5
8080143 4740

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

ORGAN-I NR 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-048(NDC:0603-4886)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 30 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
STARCH, PREGELATINIZED CORN 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorRED (rose colored) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint Code4740;V
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-048-3030 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:21695-048-4040 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2002
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Medically reviewed on Jul 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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