| NDC | 55910-037-09 |
| Set ID | 52327ed0-ea49-4d1c-b928-20ab381be9f2 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 20 mL)
- Purposes
-
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
-
Warnings
Do not use
- for children under 12 years of age
- 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
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
-
Directions
- do not take more than 6 doses in a 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- shake well before using
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
-
Principal Display Panel
Compare to the active ingredients of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough*
Maximum Strength
Fast-Acting
Mucus Relief
Severe Cough & Congestion
Multi-Symptom Relief
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Cough suppressant
Expectorant
Nasal decongestant
fl oz (mL)
For ages 12 and over
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUNG OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE,
GOODLETTSVILLE, TN 37072
- Package Label
-
INGREDIENTS AND APPEARANCE
FAST ACTING MUCUS RELIEF MAXIMUM STRENGTH SEVERE COUGH AND CONGESTION
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-037 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-037-09 266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/31/2014 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
