MAXIMUM STRENGTH MUCUS RELIEF SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

maximum strength mucus relief severe congestion and cough by

Drug Labeling and Warnings

maximum strength mucus relief severe congestion and cough by is a Otc medication manufactured, distributed, or labeled by SuperValu Inc.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	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
  • 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
• 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

• do not take more than 6 doses in any 24-hour period
• 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
• 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

• each 20 mL contains: sodium 8 mg
• store at room temperature
• do not refrigerate
• dosing cup provided

Inactive ingredients

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

Questions or comments?

1-866-932-7948

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PRINCIPAL DISPLAY PANEL

EQUALINE®

NDC: 41163-738-06

Compare toMucinex® Fast- Max™ Maximum strength Severe Congestion & Cough active ingredients*

maximum strength‡

severe congestion and cough

dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
phenylephrine HCl (nasal decongestant)

• controls cough
• relieves nasal and chest congestion
• thins and loosens mucus

6 FL OZ (180 mL)

for ages 12+

Tamper evident: do not use if printed seal under cap is broken or missing.

‡Maximum Strength per 4 hour dose.

DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

877-932-7948, supervaluprivatebrands.com

‡Maximum Strength per 4 hour dose.

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ®

Fast -Max® Maximum Strength Severe Congestion & Cough.

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MUCUS RELIEF SEVERE CONGESTION AND COUGH 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-738
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)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
propylene glycol (UNII: 6DC9Q167V3)
propyl gallate (UNII: 8D4SNN7V92)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE (viscous liquid)	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-738-06	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/07/2017

Labeler - SuperValu Inc., (006961411)