Label: MUCUS RELIEF- guaifenesin tablet, extended release
- NDC Code(s): 70677-1052-1
- Packager: Strategic Sourcing Services LLC
- This is a repackaged label.
- Source NDC Code(s): 65162-036
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 21, 2023
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
-
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?
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Principal Display Panel
COMPARE TO MUCINEX® ACTIVE INGREDIENT*
Mucus Relief
Guaifenesin 600 mg
EXPECTORANT
12 Hour Relief of:
- Chest Congestion
- 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
www.fosterandthrive.com
- Package Label
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1052(NDC:65162-036) 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:70677-1052-1 20 in 1 CARTON 03/31/2023 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 03/31/2023 Labeler - Strategic Sourcing Services LLC (116956644)