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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- 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 LABEL 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 (GUAIFENESIN) GUAIFENESIN 600 mg Inactive Ingredients Ingredient Name Strength CARBOMER 934 FD&C BLUE NO. 1 HYPROMELLOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO 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