NDC | 50580-511-01 |
Set ID | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed |
Category | HUMAN OTC DRUG LABEL |
Packager | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- 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 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.
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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?
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PRINCIPAL DISPLAY PANEL
NDC 50580-511-01
TYLENOL®
FOR ADULTSCOLD + MUCUS 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
DAY
NON-DROWSYCOOL
BURST®Alcohol 0.7%
8 fl oz (240 mL)
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INGREDIENTS AND APPEARANCE
TYLENOL COLD PLUS MUCUS SEVERE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-511 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 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 solution (UNII: 8KW3E207O2) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color BLUE Score Shape Size Flavor BERRY, MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-511-01 240 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 06/22/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/22/2015 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)