Label: TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT- acetaminophen,dextromethorphan hydrobromide, doxylamine succinate kit
- NDC Code(s): 50580-132-24
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 26, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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 productAllergy 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 ingredientsAsk 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) -
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 hourschildren 4 to under 12 years ask a doctor children under 4 years do not use - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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 productAllergy 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 ingredientsAsk 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 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
-
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 hourschildren 4 to under 12 years sk a doctor children under 4 years do not use - Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
NDC 50580-132-24
NEW
TYLENOL®
FOR ADULTSCOLD & FL
MULTI SYMPTOM
LIQUID GELSAcetaminophen,
Dextromethorphan HBr
Pain Reliever–Fever Reducer,
Cough SuppressantDAY
• HEAD + BODY ACHES
• FEVER + SORE THROAT
• COUGHActual 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
-
INGREDIENTS AND APPEARANCE
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT
acetaminophen,dextromethorphan hydrobromide, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-132 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-132-24 1 in 1 PACKAGE; Type 0: Not a Combination Product 09/25/2024 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 filledProduct Information Item Code (Source) NDC:50580-130 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MINERAL OIL (UNII: T5L8T28FGP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C RED NO. 40 (UNII: WZB9127XOA) POVIDONE (UNII: FZ989GH94E) 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 KIT 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 filledProduct Information 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 ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 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 KIT 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 09/25/2024 Labeler - Johnson & Johnson Consumer Inc. (878046358)