ORGAN-I NR- guaifenesin tablet 
American Health Packaging

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
Expectorant
200 mg

For Ages 12 & Over

30 Tablets (5 x 6)

Drug Facts

Active ingredient (in each tablet)

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

▪
adults and children 12 years and over take 1 to 2 tablets every 4 hours, do not take more than 6 doses in any 24-hour period
▪
children under 12 years do not use. This adult product is not intended for use in children under 12 years of age

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

 

FOR YOUR PROTECTION: Do not use product if blister is torn or broken.

The drug product contained in this package is from NDC # 0603-4886, Qualitest Pharmaceuticals.

Packaged and Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A,
Columbus, Ohio 43217.

078725
Rev. 05/2014

PRINCIPAL DISPLAY PANEL

ORGNA-I NR Guaifenesin Tablets USP Expectorant, 200 mg label

ORGAN-I NR
Guaifenesin Tablets USP
Expectorant

200 mg

For Ages 12 & Over

30 Tablets (5 x 6)

ORGAN-I NR 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-787(NDC:0603-4886)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
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)  
POVIDONE K15 (UNII: E54VE15114)  
Product Characteristics
ColorRED (rose colored) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 4740;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68084-787-2530 in 1 BOX, UNIT-DOSE
1NDC:68084-787-951 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/201401/31/2016
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009REPACK(68084-787)

Revised: 9/2015
Document Id: 9d045ba6-089c-40fa-8e72-43ef0b0542bc
Set id: 9a19ffd6-2adb-4dbb-b1d0-24b9f3192084
Version: 2
Effective Time: 20150915
 
American Health Packaging