Label: MUCINEX - guaifenesin tablet, extended release
- NDC Code(s): 54868-4750-0, 54868-4750-1
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 63824-008
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated December 18, 2009
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each extended-release bi-layer tablet)
Guaifenesin 600 mgClose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productiveClose
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
- children under 12 years of age: do not use
- Other information
- tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
- store between 20-25°C (68-77°F)
- Inactive ingredients
carbomer 934P, NF; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NFClose
- SPL UNCLASSIFIED SECTION
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
Relabeling of "Additional Barcode" by:Close
Physicians Total Care, Inc.
Tulsa, OK 74146
- PRINCIPAL DISPLAY PANEL - 600 mg Tablet Carton
NDC 54868-4750-0 20 Tablets
NDC 54868-4750-1 40 Tablets
600 mg guaifenesin extended-release bi-layer tablets
NEW LOOK –✔ Thins And Loosens Mucus✔ Relieves Chest Congestion
- INGREDIENTS AND APPEARANCE
guaifenesin tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-4750(NDC:63824-008) Route of Administration ORAL DEA Schedule 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white (blue and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-4750-1 2 in 1 CARTON 1 10 in 1 BLISTER PACK 2 NDC:54868-4750-0 4 in 1 CARTON 2 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021282 03/05/2003 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel