Label: TYLENOL SINUS CONGESTION AND PAIN- acetaminophen and phenylephrine hydrochloride tablet, coated
- NDC Code(s): 50580-229-02, 50580-229-24, 50580-229-48, 50580-229-72
- Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
Important: Read all product information before using. Keep this box for important information.
- ACTIVE INGREDIENT
Active ingredients (in each gelcap) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant
- for the temporary relief of:
- sinus congestion and pressure
- nasal congestion
- minor aches and pains
- helps decongest sinus openings and passages
- promotes sinus drainage
- helps clear nasal passages
- for the temporary relief of:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 gelcaps in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion 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
These could be signs of a serious condition.
Taking more than the recommended dose (overdose) may cause liver damage.
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.
- do not take more than directed (see overdose warning)
adults and children 12 years and over
- take 2 gelcaps every 4 hours
- do not take more than 12 gelcaps in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
- store between 20-25°C (68-77°F). Avoid high humidity.
- do not use if carton is opened or if blister unit is broken
- see side panel for lot number and expiration date
- Inactive ingredients
benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, colloidal silicon dioxide, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, FD&C blue #2, FD&C red #40, gelatin, hypromellose, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, stearic acid, titanium dioxide, yellow iron oxideClose
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
See New Warnings Information
CONGESTION & PAIN
Alleviates Sinus Headache & Pain
Relieves Sinus Pressure
Clears Nasal Congestion
24 RR GELCAPS
- INGREDIENTS AND APPEARANCE
TYLENOL SINUS CONGESTION AND PAIN
acetaminophen and phenylephrine hydrochloride tablet, coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-229 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (Acetaminophen) Acetaminophen 325 mg Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength benzyl alcohol ferrosoferric oxide butylparaben carboxymethylcellulose sodium silicon dioxide starch, corn D&C yellow NO. 10 edetate calcium disodium FD&C Blue NO. 1 FD&C Blue NO. 2 FD&C red NO. 40 gelatin hypromelloses methylparaben cellulose, microcrystalline polyethylene glycol polysorbate 80 powdered cellulose propylene glycol propylparaben ferric oxide red sodium lauryl sulfate sodium propionate sodium starch glycolate type a potato stearic acid titanium dioxide ferric oxide yellow Product Characteristics Color RED, GREEN (Red and green with gray subcoat band) Score no score Shape OVAL Size 19mm Flavor Imprint Code TY;S;CP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-229-02 2500 in 1 TRAY 1 2 in 1 POUCH 2 NDC:50580-229-24 2 in 1 CARTON 2 12 in 1 BLISTER PACK 3 NDC:50580-229-48 4 in 1 CARTON 3 12 in 1 BLISTER PACK 4 NDC:50580-229-72 1 in 1 CARTON 4 72 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/01/2007 Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)