MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH LIQUID POUCHES- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

Mucinex Fast-Max by

Drug Labeling and Warnings

Mucinex Fast-Max by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each pouch)	Purposes
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 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:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • nasal congestion due to a cold
• temporarily helps you cough less

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 that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever
• cough comes back, or occurs with 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

• do not take more than 6 doses in any 24-hour period
• dose as follows or as directed by a doctor
• adults and children 12 years of age and older: one 20 mL single dose pouch every 4 hours
• children under 12 years of age: do not use

Other information

• each 20 mL contains: sodium 14 mg
• store between 20-25°C (68-77°F)
• do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1 may contain this ingredient

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 20 mL Pouch Carton

MAXIMUM STRENGTH
NDC: 63824-546-44

Mucinex®
FAST-MAX®

SEVERE CONGESTION
& COUGH

LIQUID
POUCHES

Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

• ✔ Controls Cough
• ✔ Relieves Nasal
  & Chest Congestion
• ✔ Thins & Loosens
  Mucus

4 0.68 FL OZ (20 mL)
SINGLE DOSE POUCHES
Total 2.71 FL OZ (80 mL)

product not to scale

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX  SEVERE CONGESTION AND COUGH LIQUID POUCHES
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-546
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 Red No. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
propyl gallate (UNII: 8D4SNN7V92)
propylene glycol (UNII: 6DC9Q167V3)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
trisodium citrate dihydrate (UNII: B22547B95K)
water (UNII: 059QF0KO0R)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-546-44	4 in 1 CARTON	12/01/2016
1	NDC: 63824-546-01	20 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/2016

Labeler - Reckitt Benckiser LLC (094405024)