TYLENOL COLD PLUS FLU MULTI-SYMPTOM LIQUID GELS DAY PLUS NIGHT- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate kit

TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night by

Drug Labeling and Warnings

TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

TYLENOL® Cold + Flu Multi-Symptom Liquid Gels Day

ACTIVE INGREDIENT

Active ingredient (in each capsule)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg

PURPOSE

Pain reliever/fever reducer
Cough 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 DOCTOR/PHARMACIST

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

WHEN USING

When using this product do not exceed recommended dose

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

■ do not take more than directed (see overdose warning)

• 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 years: ask a doctor
• Children under 4 years: do not use

Other information

■ store at 20° to 25°C (68° to 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)

Drug Facts

TYLENOL® Cold + Flu Multi-Symptom Liquid Gels Night

Active ingredient (in each capsule)

Active ingredient (in each capsule)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

PURPOSE

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ runny nose and sneezing
■ 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
■ 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 DOCTOR/PHARMACIST

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

WHEN USING

■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

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

■ do not take more than directed (see overdose warning)

• 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 years: ask a doctor
• Children under 4 years: do not use

Other information

■ store at 20° to 25°C (68° to 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: 50580-141-03

TYLENOL ®

FOR ADULTS

COLD & FLU
MULTI SYMPTOM
LIQUID GELS

Acetaminophen,
Dextromethorphan HBr
Pain Reliever–Fever Reducer,
Cough Suppressant

DAY
HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH

Actual Size

3X16 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

3X8 LIQUID GELS

TOTAL 72 LIQUID GELS*

*LIQUID FILLED CAPSULES

INGREDIENTS AND APPEARANCE

TYLENOL COLD PLUS FLU MULTI-SYMPTOM LIQUID GELS DAY PLUS NIGHT 
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-141

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-141-03	3 in 1 PACKAGE	06/30/2025
1		1 in 1 KIT; Type 1: Convenience Kit of Co-Package

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	16
Part 2	1 BLISTER PACK	8

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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	TY;DT
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		8 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 Drug	M012	09/25/2024

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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MINERAL OIL (UNII: T5L8T28FGP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	TY;NT
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		8 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 Drug	M012	09/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/30/2025

Labeler - Kenvue Brands LLC (118772437)