SEVERE CONGESTION AND COUGH RELIEF- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Severe Congestion and Cough Relief by

Drug Labeling and Warnings

Severe Congestion and Cough Relief by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, 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

• 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 persists more than 7 days, tends to recur, or is accompanied by a fever, 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.

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
  
• only use the dose cup provided
  
• 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
  
• 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

SOUNDBODY™

Compare to the active ingredients in Mucinex® FAST-MAX™ Severe Congestion & Cough

NDC: 50844-400-45

MAXIMUM STRENGTH
Severe
Congestion and
Cough Relief

Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Cough Suppressant
Expectorant
Nasal Decongestant

Berry Flavor

Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

6 FL OZ (177 mL)

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

*This product is not manufactured or
distributed by RB Health (US) LLC, owner
of the registered trademark Mucinex®
FAST-MAX™ Severe Congestion & Cough.

50844   ORG012100445

PARENTS:
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www.StopMedicineAbuse.org

Manufactured for Big Lots Stores, Inc.
by LNK INTERNATIONAL, INC
60 Arkay Drive, Hauppauge,
NY 11788      USA
V#733000      ITEM#022700445

Sound Body 44-004

INGREDIENTS AND APPEARANCE

SEVERE CONGESTION AND COUGH RELIEF 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-400
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 (MIXED)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-400-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2021	01/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/15/2021	01/09/2025

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(50844-400) , pack(50844-400)