ORGAN-I NR- guaifenesin tablet
Qualitest Pharmaceuticals

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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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

PRINCIPAL DISPLAY PANEL

This is the label for the 100 count ORGAN-I NR tablets.

ORGAN-I NR
guaifenesin tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 30 (UNII: 2S42T2808B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, 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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0603-4886-21	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/01/2002	10/31/2016

Labeler - Qualitest Pharmaceuticals (011103059)

Name	Address	ID/FEI	Business Operations
Establishment
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE(0603-4886)

Revised: 3/2011

Document Id: 15682250-d6c3-4b35-b1f1-fc201e27a443

Set id: 5a008066-5220-4e0f-93a0-78957f050d7d

Version: 2

Effective Time: 20110304

Qualitest Pharmaceuticals