Label: MUCUS RELIEF COLD AND SINUS MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 55910-033-09
- Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 24, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
-
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- sinus congestion and pressure
- sore throat
- minor aches and pains
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these common cold and flu symptoms:
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Warnings
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.
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 everyday while using this product
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
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- diabetes
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- redness or swelling is present
- nervousness, dizziness or sleeplessness occur
- new symptoms occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- cough comes back, or occurs with rash or persistent headache
These could be signs of a serious condition.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- do not exceed recommended dose (see overdose warning)
- 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 and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
-
Principal Display Panel
Ages 12 and over
Maximum Strength
Fast-Acting
Mucus Relief
Cold & Sinus
Multi-Symptom Relief
Acetaminophen
Guaifenesin
Phenylephrine HCl
Pain reliever/fever reducer
Expectorant
Nasal decongestant
Compare to active ingredients in Mucinex® Fast-Max® Maximum Strength Cold & Sinus Liquid*
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072
888-309-9030
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Fast-Max® Maximum Strength Cold & Sinus Liquid.
- Package Label
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF COLD AND SINUS MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-033 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 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) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-033-09 266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2014 01/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2014 01/31/2025 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
