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.

----------

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60687-176(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)
POVIDONES (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AP;151
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60687-176-25	30 in 1 BOX, UNIT-DOSE	10/28/2015	12/31/2018
1	NDC:60687-176-95	1 in 1 BLISTER PACK; 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	10/28/2015	12/31/2018

Labeler - American Health Packaging (929561009)

Name	Address	ID/FEI	Business Operations
Establishment
American Health Packaging		929561009	repack(60687-176)

Revised: 1/2018

Document Id: 62991165-ec64-48a8-e053-2991aa0a54f3

Set id: b8c91723-16ab-452b-b34c-c06f8e9b097a

Version: 2

Effective Time: 20180112

American Health Packaging