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
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
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