Label: TYLENOL SINUS SEVERE- acetaminophen, guaifenesin, phenylephrine hydrochloride tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 73097-014-02, 73097-014-40, 73097-014-50 - Packager: Savings Distributors LLC
- This is a repackaged label.
- Source NDC Code(s): 50580-507
- 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.
Drug Label Information
Updated July 30, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
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Uses
■ temporarily relieves these symptoms associated with hay fever or other
respiratory allergies, and the common cold:
■ sinus congestion and pressure ■ headache
■ nasal congestion ■ minor aches and pains
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs
more productive
■ temporarily reduces fever
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Warnings
Liver warning: 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 ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- Other information
- Inactive ingredients
- Questions or comments?
- Package Label
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INGREDIENTS AND APPEARANCE
TYLENOL SINUS SEVERE
acetaminophen, guaifenesin, phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73097-014(NDC:50580-507) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 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) HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape OVAL Size 20mm Flavor MINT Imprint Code TYLENOL;1072 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73097-014-50 25 in 1 CARTON 07/22/2019 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:73097-014-40 20 in 1 CARTON 07/22/2019 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:73097-014-02 2 in 1 POUCH; Type 0: Not a Combination Product 07/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/22/2019 Labeler - Savings Distributors LLC (010527359) Establishment Name Address ID/FEI Business Operations Savings Distributors LLC 010527359 repack(73097-014)
