Acetaminophen 325 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet
Generic Name: ACETAMINOPHEN, PHENYLEPHRINE HCL
Brand Name: Topcare Sinus Congestion and Pain
- Substance Name(s):
- PHENYLEPHRINE HYDROCHLORIDE
- ACETAMINOPHEN
WARNINGS
Warnings Liver warning: This product contains acetaminophen.
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 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 occurThese 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.
INDICATIONS AND USAGE
Uses •temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: •headache •sinus congestion and pressure •nasal congestion •minor aches and pains •helps decongest sinus openings and passages •promotes sinus drainage •helps clear nasal passages •temporarily reduces fever
INACTIVE INGREDIENTS
Inactive ingredients acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
PURPOSE
Purpose Pain reliever/fever reducer Nasal decongestant
KEEP OUT OF REACH OF CHILDREN
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.
ASK DOCTOR
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
DOSAGE AND ADMINISTRATION
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
PREGNANCY AND BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
DO NOT USE
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
STOP USE
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 occurThese could be signs of a serious condition.
ACTIVE INGREDIENTS
Active ingredients (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg
ASK DOCTOR OR PHARMACIST
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin