Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg, PHENYLEPHRINE HYDROCHLORIDE 2.5mg
Labeler: Menper Distributors, Inc.
NDC Code: 53145-006
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.
Active ingredients (in each tablet)
Acetaminophen 80 mg
Phenylephrine Hydrochloride 2.5 mg
Pain reliever/ Fever Reducer
- nasal decongestion due to a common cold, hay fever or other upper respiratory allergies, nasal stuffiness, sinus congestion and pressure
- minor aches and pains associated with the common cold, sore throat, headache, tootheache and flu
Do not exceed recommended dosage. Do not give to children under 6 years of age.
Liver toxicity may occur if
- recommended dosage is exceeded
- used with other products containing acetaminophen
- used with moderate amounts of alcohol
Drug Interaction Precaution: Do not use in a child who is taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or Parkinson's Disease), or for two weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Do not give this product to a child unless directed by a doctor:
- with any other products containing acetaminophen (prescription or non-prescription)
- if you are not sure whether a drug contains acetaminophen
- if your child is allergic to acetaminophen or any other ingredients in the product
- for more than 5 days for pain
- for more than 3 days for fever
- who has heart disease, high blood pressure, thyroid disease, or diabetes
- who is taking blood thinning drug warfarin
- if your child has liver disease
Stop use and ask doctor promptly if
- pain persists and gets worse, if new symptoms occur or if redness or swelling is present because these could be signs of a serious condition
- symptoms do not improve or are accompanied by a fever
- if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting
- nervousness, dizziness, or sleeplessness occur
If pregnant or breast feeding, ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms
- Do not take more than 6 doses (12 chewable tablets) in a 24 hour period
|Children 6 to under 12 years of age||take 2 chewable tablets every 4 hours|
|Children under 6 years of age||consult a doctor|
Inactive Ingredients Aspartame, Carboxymethylcellulose Sodium, FD&C #40 aluminum lake, Flavor, Lactose, Magnesium Stearate, Polyvinyl Pirrolidone, Silicon Dioxide, Starch, Sugar and Talc.
Questions? Call 1-800-560-5223 weekdays 9 AM-4 PM EST
acetaminophen, phenylephrine hydrochloride tablet, chewable
|Labeler - Menper Distributors, Inc. (101947166)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.