Label: TYLENOL COLD PLUS FLU SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 50580-402-01, 50580-402-02, 50580-402-26, 50580-402-72
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 5, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
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
- 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.
- Overdose warning
- do not take more than directed (see overdose warning)
adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole; do not crush, chew or dissolve
- do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL
COLD + FLU
Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant,
Nasal Decongestant, Expectorant
- HEAD + BODY ACHES
- FEVER + SORE THROAT
- NASAL CONGESTION
- MUCUS + CHEST
INGREDIENTS AND APPEARANCE
TYLENOL COLD PLUS FLU SEVERE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-402 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape OVAL Size 19mm Flavor Imprint Code TYLENOL;SEVERE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-402-26 2 in 1 CARTON 07/11/2012 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-402-72 3 in 1 PACKAGE 07/11/2012 2 2 in 1 CARTON 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-402-01 2 in 1 POUCH; Type 0: Not a Combination Product 07/07/2017 4 NDC:50580-402-02 50 in 1 CARTON 07/07/2017 4 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2011 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)