TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled 
Kenvue Brands LLC

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TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS NIGHT

Drug Facts

Active ingredients (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 containsacetaminophen, 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

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ 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 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

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 50580-131-24

NEW

TYLENOL ®
FOR ADULTS


COLD & FLU

MULTI-SYMPTOM

LIQUID GELS

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine

NIGHT

• HEAD + BODY ACHES

• FEVER + SORE THROAT

• COUGH

• RUNNY NOSE

*LIQUID FILLED CAPSULES

Actual Size

24 LIQUID GELS*

tylenol-1

TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT 
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem 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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
MINERAL OIL (UNII: T5L8T28FGP)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize21mm
FlavorImprint Code TY;NT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-131-242 in 1 CARTON09/25/2024
112 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
Labeler - Kenvue Brands LLC (118772437)

Revised: 12/2024
Document Id: 290d3432-b255-7dd1-e063-6394a90af837
Set id: 1c5386c1-e45d-9dcb-e063-6294a90aff07
Version: 3
Effective Time: 20241212
 
Kenvue Brands LLC