ORGAN I NR- guaifenesin tablet
Par Pharmaceutical

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 Guaifenesin Tablets USP, 200 mg

Drug Facts

Active Ingredient

(in each immediate-release tablet)

Guaifenesin USP, 200 mg

Purpose

Expectorant

Uses

Helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm(mucus)

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

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 product is not intended for use in children under 12 years of age

adults and children 12 years and over 1 to 2 tablets every 4 hours

Children under 12 years Do not use

Other Information

store at 15-30 °C (59-86 °F)
you may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients

Colloidal silicon dioxide, FD&C red #40(Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Made in the USA
for Qualitest Pharmaceuticals,
Huntsville, AL 35811
Rev 4/15 R0

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ORGAN-I NR Guaifenesin Tablets USP, 200 mg

EXPECTORANT For age 12 and over

NDC 0603-4890-21 (100 Tablets)

ORGAN I NR
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0603-4890
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	RED	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AP;151
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0603-4890-21	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2015	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	04/27/2015	12/31/2018

Labeler - Par Pharmaceutical (011103059)

Revised: 10/2017

Document Id: 205c7bd5-da9a-4e8e-8f3c-62de90a2bdb4

Set id: f265785d-e1d5-44f9-88ca-c30518880a6e

Version: 4

Effective Time: 20171031

Par Pharmaceutical

adults and children 12 years and over	1 to 2 tablets every 4 hours
Children under 12 years	Do not use