Label: MUCUS RELIEF EXTENDED RELEASE- guaifenesin tablet
- NDC Code(s): 62011-0377-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each extended-release tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough accopanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to the active ingredient in Mucinex®*
Mucus Relief
Guaifenesin 600 mg
Expectorant
Relieves Chest Congestion
12-Hour Relief • Thins and loosens Mucus
Extended-release tablets
*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by McKesson Corp.,
via Strategic Sourcing Services LLC,
Memphis, TN 38141
- Package Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF EXTENDED RELEASE
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0377 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color blue Score no score Shape OVAL Size 16mm Flavor Imprint Code AN036 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0377-1 20 in 1 CARTON 09/30/2018 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207342 09/30/2018 Labeler - Strategic Sourcing Services LLC (116956644)