Label: MUCINEX D - guaifenesin and pseudoephedrine hydrochloride tablet, extended release
- NDC Code(s): 54868-5849-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 63824-057
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated December 23, 2009
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each extended-release bi-layer tablet) Purpose Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- 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
- you get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
- adults and children 12 years and older: 2 tablets every 12 hours; not more than 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 at 20-25°C (68-77°F)
- Inactive ingredients
carbomer 934P, NF; FD&C yellow #6 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 Carton
600 mg guaifenesin & 60 mg pseudoephedrine HCl
extended-release bi-layer tablets
EXPECTORANT & NASAL DECONGESTANT
Thins And Loosens Mucus
Clears Nasal/Sinus Congestion
18 EXTENDED-RELEASE BI-LAYER TABLETS
- INGREDIENTS AND APPEARANCE
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5849(NDC:63824-057) 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 PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color orange, 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:54868-5849-0 2 in 1 CARTON 1 9 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021585 01/07/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel