(acetaminophen and phenylephrine hydrochloride)
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
|Important: Read all product information before using. Keep this box for important information.|
- 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
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||
|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|
- 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
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 oxide
CONGESTION AND PAIN
acetaminophen and phenylephrine hydrochloride tablet, coated
|Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)|