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

severe cough and congestion by

Drug Labeling and Warnings

severe cough and congestion by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. 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

Purposes

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
• nasal congestion due to a cold
• temporarily helps you cough less

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
• 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 lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
• children under 12 years of age: do not use

Other information

• each 20 mL contains: sodium 7 mg
• store at 20-25°C (68-77°F)
• dosing cup provided
• do not refrigerate

Inactive ingredients

anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Mucinex® Fast-Max® Severe Congestion & Cough

MAXIMUM STRENGTH

Severe Cough & Congestion

DEXTROMETHORPHAN HBr – Cough suppressant

GUAIFENESIN – Expectorant

PHENYLEPHRINE HCl – Nasal decongestant

Multi-Symptom

Controls cough

Relieves nasal & chest congestion

Thins & loosens mucus

Cool Mint Flavor

6 FL OZ (180 mL)

For ages 12 & over

INGREDIENTS AND APPEARANCE

SEVERE COUGH AND CONGESTION 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-247
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	GREEN (dark green)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-247-30	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/14/2018

Labeler - CVS Pharmacy (062312574)