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

Mucus Relief Severe Congestion and Cough by

Drug Labeling and Warnings

Mucus Relief Severe Congestion and Cough by is a Otc medication manufactured, distributed, or labeled by AAFES/Your Military Exchanges. 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
  • the impulse to cough to help you get to sleep
  • nasal congestion due to a cold

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 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 (1-800-222-1222) right away.

Directions

• do not take more than 6 doses in a 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
• mL=milliliter
• 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 14 mg
• store at 20-25ºC (68-77ºF). Do not refrigerate.

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

*Compare to the active ingrediemts of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough

Maximum Strength

Mucus Relief

Severe Congestion and Cough

Multi Symptom Relief

Dextromethorphan HBr-Cough Suppressant

Guaifenesin-Expectorant

Phenylephrine HCl-Nasal Decongestant

For ages 12 and over

FL OZ (mL)

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

Manufactured for Your Millitary Exchanges

By: PL Developments

11865 S. Alamdea St, Lynwood, CA 90262

Questions or comments? Call 1-877-753-3935

Monday-Friday 9AM-5PM EST

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

Package Label

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-337
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-337-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/30/2015

Labeler - AAFES/Your Military Exchanges (001695568)