| NDC | 50580-241-01 |
| Set ID | 47c61858-72ce-409b-a3af-a63620cf7d13 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Tylenol Cold + Flu Severe
- 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 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 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion 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.
-
Directions
- do not take more than directed (see overdose warning)
- mL = milliliter
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over - take 30 mL in the dosing cup provided every 4 hours while symptoms last
- do not take more than 150 mL in 24 hours, unless directed by a doctor
children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- TYLENOL COLD MAX
- 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 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 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- 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
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion 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.
-
Directions
- do not take more than directed (see overdose warning)
- mL = milliliter
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over - take 30 mL in the dosing cup provided every 4 hours while symptoms last
- do not take more than 150 mL in 24 hours, unless directed by a doctor
children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
NDC 50580-241-01
DAYTIME
TYLENOL®
FOR ADULTS
COLD + FLU SEVERE
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant- ✔
- HEAD + BODY ACHES
- ✔
- FEVER + SORE THROAT
- ✔
- COUGH
- ✔
- NASAL CONGESTION
- ✔
- MUCUS + CHEST CONGESTION
Warming
HONEY
LEMON8 fl oz (240 mL)
NIGHTTIME
TYLENOL®
FOR ADULTS
COLD MAX
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant- ✔
- HEAD + BODY ACHES
- ✔
- FEVER + SORE THROAT
- ✔
- COUGH
- ✔
- NASAL CONGESTION
- ✔
- RUNNY NOSE
COOL
BURST®Alcohol 0.5%
8 fl oz (240 mL)
-
INGREDIENTS AND APPEARANCE
TYLENOL COLD PLUS FLU SEVERE AND TYLENOL COLD MAX
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-241 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-241-01 1 in 1 PACKAGE 10/03/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 240 mL Part 2 1 BOTTLE, PLASTIC 240 mL Part 1 of 2 TYLENOL COLD PLUS FLU SEVERE
acetaminophen,dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg in 15 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 15 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 mg in 15 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) FD&C blue no. 1 (UNII: H3R47K3TBD) FD&C red no. 40 (UNII: WZB9127XOA) FD&C yellow no. 6 (UNII: H77VEI93A8) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color BROWN, YELLOW (Amber colored) Score Shape Size Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 240 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/05/2010 Part 2 of 2 TYLENOL COLD MAX NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg in 15 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 15 mL Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine Succinate 6.25 mg in 15 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) anhydrous citric acid (UNII: XF417D3PSL) FD&C blue no. 1 (UNII: H3R47K3TBD) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color BLUE Score Shape Size Flavor BERRY, MINT (cooling berry mint flavored) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 240 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/13/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/03/2016 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)