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

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Drug Facts

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Cough suppressant

Expectorant

Nasal Decongestant

Uses

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


Other information

Inactive ingredients

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

Principal Display Panel

Maximum Strength

Mucus Relief

Severe Congestion and Cough

Dextromethorphan HBr-Cough suppressant-controls cough

Guaifenesin-Expectorant- thins mucus and relieves chest congestion

Phenylephrine HCI-nasal decongestant- relieves stuffy nose

ages 12 & over

FL OZ (mL)

COMPARE TO the active Ingredients of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough*

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

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

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL RD,

MEMPHIS, TN 38118

www.fredsinc.com

Questions or comments: 1-855-331-3733

Package Label

Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg

Fred's Pharmacy Maximum Strength Mucus Relief Severe Congestion and Cough

MUCUS RELIEF SEVERE CONGESTION AND COUGH  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-337
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-337-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/201506/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/31/201506/30/2024
Labeler - Freds Inc (005866116)

Revised: 11/2023
Document Id: d9c97921-b31d-45a4-bac6-b0b5e6ac2739
Set id: 97947377-36b2-421c-ad28-3b477d1ab29f
Version: 5
Effective Time: 20231128
 
Freds Inc