ORGAN-I NR- guaifenesin tablet

ORGAN-I NR by

Drug Labeling and Warnings

ORGAN-I NR by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

PREGNANCY OR BREAST FEEDING

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 children12 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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ORGAN-I NR 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-048(NDC: 0603-4886)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 30 (UNII: 2S42T2808B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	RED (rose colored)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	4740;V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-048-30	30 in 1 BOTTLE, PLASTIC
2	NDC: 21695-048-40	40 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2002

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK