MUCUS RELIEF COLD, FLU AND SORE THROAT MULTI SYMPTOM RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Mucus Relief Cold, Flu and Sore Throat Multi Symptom Relief by

Drug Labeling and Warnings

Mucus Relief Cold, Flu and Sore Throat 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)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  
  • minor aches and pains
    
  • sinus congestion and pressure
    
  • cough due to minor throat and bronchial irritation
  • headache
    
  • nasal congestion
  • sore throat
    
• temporarily promotes nasal and/or sinus drainage
• temporarily reduces fever
  
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
  
• with other drugs containing acetaminophen
  
• 3 or more alcoholic drinks every day while using this product
  

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• blisters
• rash
  
• skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  
• 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.
  
• if you have ever had an allergic reaction to this product or any of its ingredients
  
• for children under 12 years of age
  

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• liver disease
• thyroid disease
• heart disease
  
• difficulty in urination due to enlargement of the prostate gland
  
• high blood pressure
• diabetes
  
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur
  
• nervousness, dizziness, or sleeplessness occur
  
• fever gets worse or lasts more than 3 days
  
• redness or swelling is present
  
• 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed
  
• 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
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• use by expiration date on package
  

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

FAMILY
wellness™

COMPARE TO THE ACTIVE INGREDIENTS
IN MUCINEX® FAST-MAX® COLD,
FLU & SORE THROAT*

NDC: 55319-905-45

MAXIMUM STRENGTH

Mucus Relief
Cold, Flu & Sore Throat

Multi-Symptom Relief

Acetaminophen -
Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

For Relief of:
Headache
Fever & Sore Throat
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

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

*This product is not manufactured or
distributed by Reckitt Benckiser LLC, owner
of the registered trademark Mucinex®
FAST-MAX® Cold, Flu & Sore Throat.

50844           ORG051800545

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 44-005

INGREDIENTS AND APPEARANCE

MUCUS RELIEF COLD, FLU AND SORE THROAT MULTI SYMPTOM RELIEF 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-905
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
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)

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: 55319-905-45	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(55319-905) , PACK(55319-905)