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

  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • high blood pressure
  • diabetes
  • liver disease
  • thyroid disease
  • heart disease

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 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

Principal Display Panel

CVS
Health®

Congestion
& Headache

ACETAMINOPHEN
Pain reliever/Fever reducer
GUAIFENESIN
Expectorant
PHENYLEPHRINE HCl
Nasal decongestant

MAXIMUM STRENGTH

Multi-Symptom

• Relieves headache & fever
• Relieves nasal & chest congestion
• Thins & loosens mucus

 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
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CVS.com®
1-800-SHOP CVS    V-19849

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guaranteed.
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50844     REV0623A61501

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 ALUMINUM LAKE (UNII: 6T47AS764T)  
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
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: 7/2025
Document Id: 4cf2f7cf-aedd-412a-b2af-9b00edf8ff73
Set id: 432c3ec4-7595-4213-94e3-ce41af91804e
Version: 7
Effective Time: 20250719
 
CVS PHARMACY