Label: TYLENOL SINUS SEVERE, CVP HEALTH- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
LIL DRUG STORE TYLENOL SINUS SEVERE- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
TYLENOL SINUS SEVERE, TRAVEL BASIX- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
- NDC Code(s): 66715-6557-2, 66715-7857-2, 66715-9757-2, 66715-9757-3
- Packager: Lil Drug Store Products, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
-
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
- 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton
-
Tylenol Sinus Severe, CVP
® HEALTH, 4ct - PDP/Package
TYLENOL ®
FOR ADULTSSINUS SEVERE
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant- SINUS HEADACHE
- SINUS PRESSURE
- NASAL CONGESTION
- MUCUS + CHEST CONGESTION
DAY
NON-DROWSY[caplets image]
4
Caplets
2 POUCHES OF 2 CAPLETS EACH[CVP ® HEALTH logo]
-
Tylenol Sinus Severe, TRAVEL BASIX, 4ct - PDP/Package
TYLENOL ®
FOR ADULTSSINUS SEVERE
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant- SINUS HEADACHE
- SINUS PRESSURE
- NASAL CONGESTION
- MUCUS + CHEST CONGESTION
DAY
NON-DROWSY[caplets image]
4
Caplets
2 POUCHES OF 2 CAPLETS EACH[TRAVEL BASIX logo]
-
INGREDIENTS AND APPEARANCE
TYLENOL SINUS SEVERE, CVP HEALTH
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6557 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) STARCH, CORN (UNII: O8232NY3SJ) 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:66715-6557-2 2 in 1 CARTON 05/06/2022 1 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 Drug M012 05/06/2022 LIL DRUG STORE TYLENOL SINUS SEVERE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9757 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) STARCH, CORN (UNII: O8232NY3SJ) 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:66715-9757-2 2 in 1 CARTON 10/23/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9757-3 3 in 1 CARTON 08/15/2019 2 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 Drug M012 10/23/2017 TYLENOL SINUS SEVERE, TRAVEL BASIX
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-7857 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) STARCH, CORN (UNII: O8232NY3SJ) 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:66715-7857-2 2 in 1 CARTON 11/30/2022 1 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 Drug M012 11/30/2022 Labeler - Lil Drug Store Products, Inc (093103646)