COLD, FLU, AND SORE THROAT- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated 
CVS PHARMACY

----------

CVS 44-617 CFS Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
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.

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.
  • 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
  • thyroid disease
  • heart disease
  • high blood pressure
  • 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
  • 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 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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CVS
Health®

Compare to the active ingredients
in Maximum Strength Mucinex®
FAST-MAX® Cold, Flu & Sore Throat*

MAXIMUM STRENGTH
Cold, Flu &
Sore Throat

 ACETAMINOPHEN
Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr
Cough suppressant

GUAIFENESIN
Expectorant

PHENYLEPHRINE HCI
Nasal decongestant

Multi-Symptom

• Relieves aches, fever
& sore throat
• Controls cough
• Relieves nasal &
chest congestion
• Thins & loosens mucus

20 CAPLETS

Actual
Size

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

*This product is not manufactured or distributed by
Reckitt Benckiser LLC, owner of the registered
trademark Maximum Strength Mucinex® FAST-MAX®
Cold, Flu & Sore Throat.     50844   ORG091861709

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

CVS Health 44-617

CVS Health 44-617

COLD, FLU, AND SORE THROAT 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-431
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 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
ColorredScoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;617
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-431-092 in 1 CARTON05/02/202012/06/2024
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 DrugM01205/02/202012/06/2024
Labeler - CVS PHARMACY (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(69842-431) , pack(69842-431)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(69842-431)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(69842-431)

Revised: 11/2023
Document Id: 4607e85f-e560-4200-a047-5db9fcfbe9e7
Set id: bb0a9a70-13ef-4d42-87e5-d8426f1ff21a
Version: 10
Effective Time: 20231118
 
CVS PHARMACY