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Guaifenesin by Contract Pharmacy Services-PA

Medically reviewed on April 19, 2018

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: Contract Pharmacy Services-PA
NDC Code: 67046-251

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.

FULL PRESCRIBING 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 ‚Äč REPACKAGED BY: COUPLER ENTERPRISES INC. NDJA 4/19/18

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

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

Guaifenesin 200 mg

Expectorant

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-251(NDC:0904-5154)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
Product Characteristics
ColorpinkScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code44;588
Contains    
Packaging
#Item CodePackage Description
1NDC:67046-251-3030 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/15/2018
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIOperations
Coupler Enterprises Inc.945429777repack(67046-251)

 
Contract Pharmacy Services-PA

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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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