NDC | 63868-871-20 |
Set ID | 9f875e90-b508-47f4-a8d5-94363e2f8edc |
Category | HUMAN OTC DRUG LABEL |
Packager | QUALITY CHOICE (Chain Drug Marketing Association) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA207342 |
- 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?
-
Principal Display Panel
Compare to the Active Ingredient in Mucinex®
Mucus Relief
Guaifenesin Extended-Release
Tablets 600 mg
Expectorant
12-HOUR Relief
- Relieves 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 C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
- Package Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF EXTENDED RELEASE
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-871 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:63868-871-20 20 in 1 CARTON 12/31/2018 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 12/31/2018 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)