MUCUS RELIEF SEVERE CONGESTION AND COUGH MULTI SYMPTOM RELIEF- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Mucus Relief Severe Congestion and Cough Multi Symptom Relief by

Drug Labeling and Warnings

Mucus Relief Severe Congestion and Cough Multi Symptom Relief by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc, LNK International, Inc.. 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

Purpose

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
• diabetes
  
• high blood pressure
  
• thyroid disease
  
• difficulty in urination due to enlargement of the 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 exceed recommended dosage.

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 (1-800-222-1222) right away.

Directions

• do not take more than 6 doses in any 24-hour period
  
• mL = milliliter; FL OZ = fluid ounce
  
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  
• children under 12 years: do not use
  

Other information

• each 20 mL contains: sodium 10 mg
  
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  
• use by expiration date on package
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display Panel

FAMILY
wellness™

COMPARE TO THE ACTIVE INGREDIENTS
IN MUCINEX® FAST-MAX® SEVERE
CONGESTION & COUGH*

NDC: 55319-904-45

MAXIMUM STRENGTH

Mucus Relief
Severe Congestion & Cough
Multi-Symptom Relief

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

For Relief of:
Cough
Nasal & Chest Congestion
Thins & Loosens Mucus

AGES 12 & OVER

Berry
Flavored

6 FL OZ (177 mL)

OTC
network

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

*This product is not manufactured or
distributed by Reckitt Benckiser LLC,
owner of the registered trademark
Mucinex® FAST-MAX® Severe Congestion
& Cough.
50844                ORG121600445

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD.
MATTHEWS, NC 28105

NOT 100% SATISFIED?
Return package and unused product
within 30 days to any Family Dollar store
for a refund (with receipt) or exchange.

Family Wellness 44-004

INGREDIENTS AND APPEARANCE

MUCUS RELIEF SEVERE CONGESTION AND COUGH MULTI SYMPTOM RELIEF 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-904
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-904-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2017

Labeler - Family Dollar Services Inc (024472631)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(55319-904) , PACK(55319-904)