MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH- mucinex congestion and cough maximum strength 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 Good Neighbor Pharmacy, Aaron Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Dextromethorphan HBr 20mg

Guaifenesin 400 mg

Phenylephrine HCl 10mg

Purpose

Dextromethorphan............................Cough suppressant

Guaifenesin................................Expectorant

Phenylephrine HCL..........................Nasal Decongestant

Uses

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, helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

warnings

for children under 12 years of age

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

persistent or chronic cough such as occurs with smoking, astha, chrinic 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

cough lasts more than 7 days, comes back, or occurs with 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 1-800-222-1222 immediately.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not exceed recommended dosage

use dosage cup provided

do not take more than 6 doses in a 24 hour period

do not use dosing cup with other products

dose as follows or as directed by a doctor mL=milliliter

children under 12 years-do not use

adults and children 12 years and older-20mL every 4 hours

Other information

each 20mL contains potassium 6mg, sodium 13mg

store at room temperature

do not refrigerate

Inactive ingredients

citric acid, dextrose, flavors, glycerin, methyl paraben, potassium sorbate, propylene glycol, propyl paraben, purified water, red 33, red 40, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Principal Display Panel

Maximum Strength

Mucus Relief

Severe Congestion and Cough

Cought Suppressant

(Dextromethorphan HBr)

Chest Congestion and Mucus

(Guaifenesin)

Stuffy Nose

(Phenylephrine HCl)

Mucus, Stuffy Nose, Chest Congestion, Cough

For Ages 12 and over

Distrubted By AmerisourceBergen

1300 Morris Drive Chesterbrook PA 19087

Visit us at www.goodneighborpharmacy.com

Questions or comments? 1 866 534 4631

6 fl oz 177 mL

 

INGREDIENTS AND APPEARANCE

MUCUS RELIEF SEVERE CONGESTION AND COUGH  MAXIMUM STRENGTH
mucinex congestion and cough maximum strength liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-219
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
PROPYL GALLATE (UNII: 8D4SNN7V92)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-219-30	177 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/04/2013

Labeler - Good Neighbor Pharmacy (007914906)

Registrant - Aaron Industries, Inc. (113044205)

Establishment
Name	Address	ID/FEI	Business Operations
Aaron Industries, Inc.		113044205	manufacture(46122-219) , analysis(46122-219)