MUCUS RELIEF COLD FLU AND SORE THROAT MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Raritan Pharmaceuticals Inc

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.

----------

DRx CHOICE® Max Strength Mucus Relief Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg 

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:
nasal congestion
sinus congestion and pressure
cough due to minor throat and bronchial irritation
minor aches and pain
sore throat
headache
temporarily reduces fever
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 6 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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

liver disease
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)

Ask a doctor or pharmacist before use if you are

 taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. 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 take more than directed (see overdose warning)
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.  
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 8 mg
Store at room temperature
do not refrigerate.
dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Principal Display Panel

DRx CHOICE®

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat *

Maximum Strength

Mucus Relief

Cold, Flu & Sore Throat

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr • Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCI 10 mg • Nasal Decongestant

Relieves Headache, Fever & Sore Throat
Controls Cough
Relieves Nasal & Chest Congestion 
Thins & Loosens Mucus

FOR AGES 12 +

9 FL OZ (266 mL)

*This product is not manufactured or distributed by Reckitt Benckiser, Distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat.

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

Maximum Strength per 4 hour dose.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

*This product is not manufactured or distributed by Reckitt Benckiser, the distributer of Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat.

PEEL CORNER TO READ COMPELETE DRUG FACTS AND INFORMATION

Package Label

Drx Choice Mucus Relief Cold Flu and Sore Throat
MUCUS RELIEF COLD FLU AND SORE THROAT  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-737
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
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)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-737-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/05/2019
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2023
Document Id: 1517cebe-1dda-41ed-a58c-f7cb96b99bc1
Set id: 2cb3e17f-3858-4773-a53f-0860ae6ff1b9
Version: 5
Effective Time: 20230902
 
Raritan Pharmaceuticals Inc