TYLENOL SINUS SEVERE- acetaminophen, guaifenesin, phenylephrine hydrochloride tablet, coated 
Savings Distributors LLC

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.

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Tylenol Sinus Severe

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

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

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)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dose

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ do not take more than directed (see overdose warning)


adults and children 12 years ■ take 2 caplets every 4 hours
and over ■ 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

■ each caplet contains: sodium 3 mg

■ store between 20-25°C (68-77°F)

■ do not use if pouch is tron or damaged

Inactive ingredients

carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Package Label

Package Label

TYLENOL SINUS SEVERE 
acetaminophen, guaifenesin, phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-014(NDC:50580-507)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVALSize20mm
FlavorMINTImprint Code TYLENOL;1072
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73097-014-5025 in 1 CARTON07/22/2019
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:73097-014-4020 in 1 CARTON07/22/2019
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:73097-014-022 in 1 POUCH; Type 0: Not a Combination Product07/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/22/2019
Labeler - Savings Distributors LLC (010527359)
Establishment
NameAddressID/FEIBusiness Operations
Savings Distributors LLC010527359repack(73097-014)

Revised: 7/2019
Document Id: 8eecae01-fb90-960f-e053-2a95a90a29e8
Set id: 8eecb3f0-eb5e-e847-e053-2995a90a86bd
Version: 1
Effective Time: 20190730
 
Savings Distributors LLC