Label: MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH- dextromethorphan hydrobromide, guaifenesin capsule, liquid filled
- NDC Code(s): 72854-153-16
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 28, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
-
Uses
Uses:
■ helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of
bothersome mucus and make coughs more
productiveTemporarily 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 -
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
■ persistent or chronic cough such as occurs with
smoking, asthma, chronic bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)When using this product do not use more than directed
Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or
occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.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
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH
dextromethorphan hydrobromide, guaifenesin capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-153 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL SOLUTION (UNII: 8KW3E207O2) HYPROMELLOSES (UNII: 3NXW29V3WO) Product Characteristics Color green Score no score Shape OVAL Size 16mm Flavor Imprint Code AR08 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-153-16 2 in 1 CARTON 06/01/2024 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/01/2024 Labeler - RB Health (US) LLC (081049410)
