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

Cold, Flu, and Sore Throat by

Drug Labeling and Warnings

Cold, Flu, and Sore Throat by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• temporarily relieves these common cold and flu symptoms:
  
  • nasal congestion
  • sore throat
  • headache
  • cough
    
  • minor aches and pains
    
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily reduces fever
  

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
  
• with other drugs containing acetaminophen
  
• 3 or more alcoholic drinks every day while using this product
  

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

• blisters
• rash
• skin reddening
  

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

• do not take more than directed
  
• do not take more than 12 caplets in any 24-hour period
  
• adults and children 12 years and over: take 2 caplets every 4 hours
  
• children under 12 years: do not use
  

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  
• see end flap for expiration date and lot number
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

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®

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

*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

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

CVS Health 44-617

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-431
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (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 (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
Color	RED	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;617
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-431-09	2 in 1 CARTON	05/02/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/02/2020

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(69842-431)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(69842-431)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(69842-431)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(69842-431)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(69842-431)