Label: TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
- NDC Code(s): 50580-131-24
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 12, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
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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
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
NDC 50580-131-24
NEW
TYLENOL ®
FOR ADULTS
COLD & FLUMULTI-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 CAPSULESActual Size
24 LIQUID GELS*
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INGREDIENTS AND APPEARANCE
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-131 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength 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 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 NDC:50580-131-24 2 in 1 CARTON 09/25/2024 1 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 09/25/2024 Labeler - Kenvue Brands LLC (118772437)