Tylenol® Cold + Flu Multi-symptom Liquid Gels Day + Night

SPL v3

SPL

SPL Set ID 1c5578e6-7e67-c467-e063-6294a90a6e0b

Route

ORAL

Published

Effective Date 2024-07-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (15 mg)

Inactive Ingredients

Polyethylene Glycol, Unspecified Mineral Oil Fd&c Yellow No. 6 Water Gelatin Glycerin Propylene Glycol Fd&c Red No. 40 Povidone Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance

Imprint: TY;NT Shape: oval Color: orange Color: green Size: 21 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-25

Description

TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY Drug Facts

Medication Information

Description

TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY Drug Facts

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ temporarily reduces fever

Section 42229-5

TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose

Section 50568-5

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

warfarin

Section 53414-9

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

Section 55105-1

Active ingredient (in each caplsule)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant

Warnings

Warnings

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

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

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

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.

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

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.

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)

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

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.

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

■ taking sedatives or tranquilizers

Structured Label Content

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ temporarily reduces fever

Section 42229-5 (42229-5)

TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

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

warfarin

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredient (in each caplsule)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant

Warnings

Warnings

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

Do Not Use (Do not use)

Liver Warning (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

Overdose Warning (Overdose warning)

Other Information (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

Sore Throat Warning (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.

Inactive Ingredients (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? (Questions or comments?)

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

Principal Display Panel (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

When Using This Product (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 (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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ temporarily reduces fever", "42229-5": "TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not exceed recommended dose", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredient (in each caplsule) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant", "Warnings": "Warnings", "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", "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", "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", "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.", "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", "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.", "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)", "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", "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.", "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 ■ taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:46.928562 · Updated: 2026-03-14T23:05:45.354656