Label: MUCOSAN MAX WITH ACETAMINOPHEN- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid
- NDC Code(s): 53145-696-06
- Packager: Menper Distributors, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2024
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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
- INDICATIONS & USAGE
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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.
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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.
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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
- WHEN USING
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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
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
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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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUCOSAN MAX WITH ACETAMINOPHEN
acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquidProduct 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)