TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT- acetaminophen,dextromethorphan hydrobromide, doxylamine succinate 
Kenvue Brands LLC

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TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY + NIGHT

TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY

Drug Facts

Active ingredient (in each caplsule)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ temporarily reduces fever

Warnings

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:

■ 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
■ persistent or chronic cough such as occurs with smoking, asthma 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 dose

Stop use and ask a doctor if

■ pain 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.

Overdose warning

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

adults and children 12 years
and over
■ take 2 capsules every 4 hours while symptoms last
■ do not take more than 8 capsules in 24 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

Other information

■ store between 20-25°C (68-77°F)
■ avoid high humidity and excessive heat above 40°C (104°F)
■ protect from light
do not use if blister unit is torn or broken

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin,lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water,sorbitol sorbitan solution

Questions or comments?

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

TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS NIGHT

Drug Facts

Active ingredient (in each capsule) Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ runny nose and sneezing

■ 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:

■ 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

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate gland

■ persistent or chronic cough such as occurs with smoking, asthma 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

■ taking sedatives or tranquilizers

When using this product

do not exceed recommended dose

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ pain 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.

Overdose warning

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

adults and children 12 years and over■ take 2 capsules every 6 hours while symptoms last
■ do not take more than 8 capsules in 24 hours
children 4 to under 12 yearssk a doctor
children under 4 yearsdo not use

Other information

■ store between 20-25°C (68-77°F)
■ avoid high humidity and excessive heat above 40°C (104°F)
■ protect from light
do not use if blister unit is torn or broken​

Inactive ingredients

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin,lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water,sorbitol sorbitan solution

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-132-24

NEW

TYLENOL®


FOR ADULTS

COLD & FL

MULTI SYMPTOM
LIQUID GELS

Acetaminophen,

Dextromethorphan HBr

Pain Reliever–Fever Reducer,
Cough Suppressant

DAY

• HEAD + BODY ACHES
• FEVER + SORE THROAT
• COUGH

Actual Size

16 LIQUID GELS

Acetaminophen,

Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever-Fever Reducer,

Cough Suppressant, Antihistamine

NIGHT

• HEAD + BODY ACHES
• FEVER + SORE THROAT
• COUGH

• RUNNY NOSE

Actual Size

8 LIQUID GELS

TOTAL 24 LIQUID GELS*

*LIQUID FILLED CAPSULES

tylenol-1

TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT 
acetaminophen,dextromethorphan hydrobromide, doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-132
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-132-241 in 1 PACKAGE; Type 0: Not a Combination Product09/25/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16 
Part 21 BLISTER PACK
Part 1 of 2
TYLENOL COLD PLUS FLU MULTI-SYMPTOM LIQUID GELS DAY 
acetaminophen, dextromethorphan hydrobromide capsule, liquid filled
Product Information
Item Code (Source)NDC:50580-130
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
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MINERAL OIL (UNII: T5L8T28FGP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize21mm
FlavorImprint Code TY;DT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 KIT
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/25/2024
Part 2 of 2
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT 
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
Product Information
Item Code (Source)NDC:50580-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize21mm
FlavorImprint Code TY;NT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/25/2024
Labeler - Kenvue Brands LLC (118772437)

Revised: 12/2024
Document Id: 290d8ab1-f28d-00cb-e063-6394a90adf30
Set id: 1c5578e6-7e67-c467-e063-6294a90a6e0b
Version: 3
Effective Time: 20241212
 
Kenvue Brands LLC