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ORGAN I NR by Par Pharmaceutical

Medically reviewed on October 31, 2017

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: Par Pharmaceutical
NDC Code: 0603-4890

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 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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-4890
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorREDScorescore with uneven pieces
ShapeROUNDSize10mm
FlavorImprint CodeAP;151
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-4890-21100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/27/201512/31/2018
Labeler - Par Pharmaceutical (011103059)

 
Par Pharmaceutical

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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