MUCOSAN MAX WITH ACETAMINOPHEN- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid

Mucosan Max with Acetaminophen by

Drug Labeling and Warnings

Mucosan Max with Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 20 mL) Purpose

Acetaminophen, 650 mg................................Pain reliever/Fever reducer

Dextromethorphan HBr, 20 mg......................Cough suppressant

Guaifenesin, 400 mg.............................. .......Expectorant

Phenylephrine HCl, 10 mg.............................Nasal Decongestant

PURPOSE

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves these common cold and flu symptoms:
• nasal congestion
• cough
• minor aches and pains
• sore throat
• headache
• temporarily reduces fever
• helps loosen phlem (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

WARNINGS

Warnings

Liver warning: this product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 4 doses (20 mL each) in 24 hours, wich is the maximum daily amount for this product
• 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 and rash. If 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

Do not use

• With any other drug containing acetamonophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• if you are 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 a MAOI, ask a doctor or Pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• breathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)
• trouble urination due to enlarged prostate gland.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

WHEN USING

When using this product do not use more than direct.

STOP USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough comes back or occurs with fever, rash, or persistant headache
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast - feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• do not take more than direct
• do not take more than 4 doses in any 24 hours
• this adult strength product is not intended for use in children under 12 years of age
• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• dose as follows

• age: dose
• adults and children 12 years of age and older: 20 mL every 4 hours
• children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

• each (20 mL) contains: sodium 10mg
• store between 15-30°C (59-86°F)
• do not refrigerate.

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments?

1-800-560-5223 Monday to Friday 9am-4pm, Eastern Time

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCOSAN MAX WITH ACETAMINOPHEN 
acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-696
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-696-06	1 in 1 CARTON	11/01/2024
1		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/01/2024

Labeler - Menper Distributors, Inc. (101947166)

Registrant - Menper Distributors, Inc. (101947166)