Guaifenesin by Contract Pharmacy Services-PA / Coupler Enterprises Inc. GUAIFENESIN tablet

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Contract Pharmacy Services-PA, Coupler Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• HIGHLIGHTS OF PRESCRIBING INFORMATION

  Guaifenesin 200mg USP 251 "These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"

  DOSAGE AND ADMINISTRATION

  Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 yearsof age and over 1 to 2 tablets every4 hours children 6 to under 12 yearsof age ½ to 1 tablet every4 hours children under 6 years of age consult a physician (3)

  INDICATIONS AND USAGE

  helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (6)

  Revised: 4/2018

• Table of Contents

  FULL PRESCRIBING INFORMATION: CONTENTS*

  * Sections or subsections omitted from the full prescribing information are not listed.

PATIENT MEDICATION INFORMATION

Major 44-588 Major Pharmaceuticals LNK International, Inc. LNK International, Inc. LNK International, Inc. LNK International, Inc. Guaifenesin Guaifenesin GUAIFENESIN GUAIFENESIN MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE STEARIC ACID FD&C RED NO. 40 SILICON DIOXIDE dark 44;588 Active ingredient (in each immediate-release tablet) Guaifenesin 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 occurs with 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 do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 yearsof age and over 1 to 2 tablets every4 hours children 6 to under 12 yearsof age ½ to 1 tablet every4 hours children under 6 years of age consult a physician Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package Inactive ingredients FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid Questions or comments? (800) 616-2471 Principal Display Panel NDC: 0904-5154-60 MAJOR® GUAIFENESIN TABLETSGuaifenesin 200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 100 Tablets Immediate Release 50844 REV0812B58812Distributed by MAJOR® PHARMACEUTICALS 31778 Enterprise Drive, Livonia, MI 48150 USARe-Order No. 238163 M-17 Rev. 04/13 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Major 44-588 Major 44-588 ​ REPACKAGED BY: COUPLER ENTERPRISES INC. NDJA 4/19/18

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 yearsof age and over 1 to 2 tablets every4 hours children 6 to under 12 yearsof age ½ to 1 tablet every4 hours children under 6 years of age consult a physician

DOSAGE & ADMINISTRATION

WARNINGS

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 occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use

INACTIVE INGREDIENT

Inactive ingredients FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

INDICATIONS & USAGE

ACTIVE INGREDIENT

Guaifenesin 200 mg

PURPOSE

Expectorant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67046-251(NDC:0904-5154)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;588
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67046-251-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/15/2018

Labeler - Contract Pharmacy Services-PA (945429777)

Establishment
Name	Address	ID/FEI	Business Operations
Coupler Enterprises Inc.		945429777	repack(67046-251)