TYLENOL COLD PLUS FLU SEVERE- acetaminophen, dextromethorphan hbr,phenylephrine hcl, guaifenesin tablet 
TYLENOL COLD PLUS FLU SEVERE- acetaminophen, dextromethorphan hbr,phenylephrine hcl, guaifenesin tablet 
Lil' Drug Store Products, Inc.

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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TYLENOL®

COLD + FLU SEVERE

Drug Facts

Drug Facts

Uses

Warnings

Liver warning

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

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

  • skin reddening
  • blisters
  • rash

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dose

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 (see OVERDOSE WARNING)

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
children under 12 yearsask a doctor

Other Information

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide

Questions or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Active Ingredient ( in each tablet)

Purpose

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant


PRINCIPAL DISPLAY PANEL 4ct Package

TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE

Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION

2 Pouches of 2 Caplets each

Tylenol C and F 4ct


PRINCIPAL DISPLAY PANEL 25ct Box

TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE

Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION

25 Pouches of 2 Caplets each

Tylenol Cold 25ct


PRINCIPAL DISPLAY PANEL 30ct Box

TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE

Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION

30 Pouches of 2 Caplets each

Tylenol Cold 30ct

CVP 4 Count Carton

TYLENOL ®
FOR ADULTS
COLD + FLU
SEVERE

Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST
CONGESTION

4 Caplets

2 Pouches of 2 Caplets each

CVP

HEALTH

Tylenol Cold and Flu Severe CVP 4ct

TYLENOL COLD PLUS FLU SEVERE 
acetaminophen, dextromethorphan hbr,phenylephrine hcl, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-8062
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
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize19mm
FlavorImprint Code TYLENOL;SEVERE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-8062-330 in 1 BOX08/22/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:29485-8062-225 in 1 BOX07/10/2020
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01208/22/2017
TYLENOL COLD PLUS FLU SEVERE 
acetaminophen, dextromethorphan hbr,phenylephrine hcl, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-8060
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
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize19mm
FlavorImprint Code TYLENOL;SEVERE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-8060-42 in 1 PACKAGE04/18/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01204/18/2017
TYLENOL COLD PLUS FLU SEVERE 
acetaminophen, dextromethorphan hbr,phenylephrine hcl, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6556
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
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize19mm
FlavorImprint Code TYLENOL;SEVERE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6556-42 in 1 CARTON08/25/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01208/25/2017
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 7/2023
Document Id: 00c7d82f-6568-f10e-e063-6394a90a4773
Set id: d3315908-ebc3-e7cd-e053-2a95a90ae9a3
Version: 8
Effective Time: 20230718
 
Lil' Drug Store Products, Inc.