Fast maximum severe congestion and cough solution

Drug facts

Active ingredients (in each20 mL (4 tsp) dose)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Phenylephrine HCl, USP10 mg

Purposes

Cough suppressant
Expectorant
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
    • 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 Parkinsons 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. Avoid foods or beverages that contain caffeine

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 persistent headache.

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 (1-800-222-1222).

Directions

  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter; tsp = teaspoon
  • Adults and children 12 years and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
  • Children under 12 years of age: do not use unless directed by a doctor

Other information

  • Each 20 mL contains:sodium 14 mg
  • Store at 20-25C (68-77F)
  • tamper evident: do not use if printed seal under cap is torn or missing
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions or comments


1-855-274-4122

You may also report side effects to this phone number.

Distributed by:
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087






Ingredients and appearance - Product information

Fast maximum severe congestion and cough solution- Dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 46122-360
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 20 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 20 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 20 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Pineapple ( UNII: 2A88ZO081O)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Propyl gallate ( UNII: 8D4SNN7V92)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Trisodium citrate dihydrate ( UNII: B22547B95K)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color BLUE Flavor PINEAPPLE

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 46122-360-30 177mL in 1 BOTTLE 2016/05/19

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2016/05/19

Labeler - Amerisource Bergen( 007914906)

Establishment

Name ID/FEI Business Operations
Amerisource Bergen 007914906 MANUFACTURE( 46122-360)

Package label-principal display panel 6 fl oz (177 ml bottle)

NDC 46122-360-30

ComparetoMucinex®
FAST-MAX TMSevere
Congestion & Cough
active ingredients*

GOOD
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PHARMACY ®

MAXIMUM STRENGHT**
Fast Maximum

Severe Congestion
& Cough


Each dose per 20 mL (4 tsp) of oral solution contains:

20mg - dextromethorphan HBrUSP (cough suppressant)

400 mg - guaifenesin USP (expectorant)

10 mg - phenylephrine HCl USP (nasal decongestant)


  • Controls Cough
  • RelievesNasal & Chest Congestion
  • Thins & Loosens Mucus

For Ages 12+ 6 FL OZ (177 mL)