Label: GUAIFENESIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-251-30 - Packager: Contract Pharmacy Services-PA
- This is a repackaged label.
- Source NDC Code(s): 0904-5154
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 19, 2018
If you are a consumer or patient please visit this version.
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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
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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
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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
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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
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin tabletProduct 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)
