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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Maximum Strength Severe Congestion and Cough Relief

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


Purpose

Cough suppressant

Expectorant

Nasal decongestant

Uses


Warnings

Do not use

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 fever
  • cough comes back, or occurs with 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

Other information

Inactive ingredients

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

Principal Display Panel

compare to Mucinex Fast-Max Severe Congestion and Cough active ingredients

Maximum Strength severe congestion and cough relief

Dextromethorphan HBr 20 mg - cough suppressant

Guaifenesin 400 mg - expectorant

Phenylephrine HCl 10 mg - nasal decongestant

Relieves nasal and chest congestion,

Soothes cough,

Thins and loosens mucus

for ages 12 plus

6 fl oz (177 mL)

Label

SEVERE CONGESTION AND COUGH RELIEF 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-817
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorblue (blue colored clear liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-817-58177 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/11/2015
Labeler - Safeway (009137209)

Revised: 1/2022
Document Id: 8e71a961-9514-4c4e-96ce-58ee830427b0
Set id: 2b1355ba-6b19-4847-8ad9-52e11c3057c1
Version: 3
Effective Time: 20220112
 
Safeway