MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Mucus Relief Severe Congestion and Cough by

Drug Labeling and Warnings

Mucus Relief Severe Congestion and Cough by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 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 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)

​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 a fever
• cough 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 (1-800-222-1222) right away. 

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 products
• shake well before using
• 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 17 mg
• store between 20-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® FAST-MAX® SEVERE CONGESTION & COUGH ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Mucus Relief

Severe Congestion and Cough

DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT

GUAIFENESIN 400 mg EXPECTORANT

PHENYLEPHRINE HCI 10 mg   NASAL DECONGESTANT

MULTI-SYMPTOM RELIEF:

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

FOR AGES 12 +

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.

DISTRIBUTED BY TOPCO ASSOCIATED LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

Package Label

TOPCARE HEALTH Maximum Strength Mucus Relief

INGREDIENTS AND APPEARANCE

MUCUS RELIEF SEVERE CONGESTION AND COUGH  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-037
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: 36800-037-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/28/2015

Labeler - TOP CARE (Topco Associates LLC) (006935977)