CONGESTION AND HEADACHE- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated 
CVS PHARMACY

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CVS 44-615

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses

Warnings

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

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

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

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.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • diabetes
  • high blood pressure
  • heart disease
  • thyroid disease
  • difficulty in urination due to enlargement of the 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 exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. 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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

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Compare to active ingredients in Mucinex® FAST-MAX® Congestion & Headache*

MAXIMUM STRENGTH

Congestion & Headache

ACETAMINOPHEN
Pain reliever/Fever reducer

GUAIFENESIN
Expectorant

PHENYLEPHRINE HCl
Nasal decongestant

Multi-Symptom

Actual Size

30 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by:
CVS Pharmacy, Inc. 
One CVS Drive
Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com®   
1-800-SHOP CVS    V-19849
CVS® Quality
Money Back Guarantee

*This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Mucinex®
FAST-MAX® Congestion & Headache.                                                                                            50844 ORG032061501

CVS 44-615

CVS 44-615

CONGESTION AND HEADACHE 
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-651
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;615
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-651-013 in 1 CARTON10/14/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/30/2013
Labeler - CVS PHARMACY (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(69842-651)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(69842-651) , pack(69842-651)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(69842-651)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(69842-651)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(69842-651)

Revised: 9/2023
Document Id: 0356707f-b9fd-4977-b551-04c22cc079bd
Set id: 432c3ec4-7595-4213-94e3-ce41af91804e
Version: 5
Effective Time: 20230923
 
CVS PHARMACY