TYLENOL COLD PLUS FLU PLUS CHEST CONGESTION- acetaminophen, guaifenesin tablet, film coated

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Purpose

Pain reliever/fever reducer

Expectorant

Uses

■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive
■ 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 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, 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 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

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

• Adults and children 12 years and over: ■ take 2 caplets every 4 hours while symptoms last ; ■ do not take more than 10 caplets in 24 hours
• Children under 12 years: ■ ask a doctor

Other information

■ each caplet contains: sodium 3 mg
■ store between 20-25°C (68-77°F)
■ do not use if blister unit is torn or broken

Inactive ingredients

croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose,
pregelatinized starch, titanium dioxide, triacetin

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NEW

NDC: 50580-584-24

TYLENOL ®

FOR ADULTS

COLD + FLU +

CHEST CONGESTION

Acetaminophen, Guaifenesin
Pain Reliever-Fever Reducer, Expectorant

HEADACHE + BODY ACHES
FEVER
SORE THROAT
MUCUS + CHEST CONGESTION

COOL COATED

Actual Size

24 CAPLETS

INGREDIENTS AND APPEARANCE

TYLENOL COLD PLUS FLU PLUS CHEST CONGESTION 
acetaminophen, guaifenesin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-584
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRIACETIN (UNII: XHX3C3X673)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	TYLENOL;1488
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-584-50	2500 in 1 CASE	06/01/2027
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 50580-584-10	50 in 1 CARTON	06/01/2027
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 50580-584-24	2 in 1 CARTON	03/06/2026
3		12 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	03/06/2026

Labeler - Kenvue Brands LLC (118772437)