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ORGAN-I NR by American Health Packaging

Medically reviewed on January 12, 2018

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: American Health Packaging
NDC Code: 60687-176

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
Expectorant
200 mg

For Ages 12 & Over

30 Tablets (5 x 6)

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. These 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
  • 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 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

colloidal silicon dioxide, FD&C red #40 (Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, 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 # 0603-4890, Qualitest Pharmaceuticals.

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

717625
Rev. 07/2015OS

PRINCIPAL DISPLAY PANEL

NDC 60687-176-25

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:60687-176(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 
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorredScore2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeAP;151
Contains    
Packaging
#Item CodePackage Description
1NDC:60687-176-2530 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:60687-176-951 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/28/201512/31/2018
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIOperations
American Health Packaging929561009repack(60687-176)

 
American Health Packaging

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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