Prescribing information (package insert) - Guaifenesin and Pseudoephedrine Extended-Release
Drug Facts
| Active ingredients (in each extended-release bi-layer tablet) | Purpose |
| Guaifenesin 600 mg | Expectorant |
| Pseudoephedrine HCl 60 mg | Nasal Decongestant |
Uses
- 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
Warnings
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
- diabetes
- 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)
When using this product
- do not use more than directed
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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, NF
How Supplied
Mucinex®D is supplied by Dispensing Solutions Inc. as follows:
| NDC | Strength | Quantity/Form | Color | Source NDC |
| 68258-3035-1 | 600 mg / 60 mg | 18 Tablets | WHITE | 63824-057-18 |
This product was:
Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
And Relabeled By:
Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States