MUCUS RELIEF COLD AND SINUS MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl liquid 
P & L Development, LLC

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.

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Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg 

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer 

Expectorant

Nasal decongestant

Uses

Warnings

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

 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:

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
  • diabetes
  • thyroid disease
  • high blood pressure
  • 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Principal Display Panel

Compare to active ingredients in

Mucinex® Fast-Max® Maximum Strength Cold & SinusLiquid*

maximum strength

Mucus relief

cold & sinus multi-symptom relief

acetaminophen

guaifenesin

 phenylephrine

for ages 12 & over

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

FL OZ (mL)

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90260

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Fast-Max®  Maximum Strength Cold &Sinus Liquid

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

Package Label

Acetaminophen 650mg Guaifenesin 400mg Phenylephrine HCI 10mg

Readyincase mucus relief cold & sinus maximum strength

MUCUS RELIEF  COLD AND SINUS MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0335
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-0335-9237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/201512/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/28/201512/31/2024
Labeler - P & L Development, LLC (101896231)

Revised: 5/2023
Document Id: 1d7366ba-a1ea-4e5b-8b96-c339e09be9e1
Set id: bc1cab2f-5d59-42fc-8837-b2257f1347f2
Version: 4
Effective Time: 20230518
 
P & L Development, LLC