Dosage form: tablet, chewable
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg
Labeler: Pernix Therapeutics, LLC
NDC Code: 65224-545
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 chewable tablet)||Purpose|
|Diphenhydramine HCl 12.5 mg||Antihistamine|
|Phenylephrine HCl 5 mg||Nasal Decongestant|
- runny nose
- itching of the nose or throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies
- nasal congestion due to the common cold
- may cause excitability, especially in children
- do not use 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.
- heart disease
- thyroid disease
- high blood pressure
- a breathing problem such as emphysema, chronic bronchitis or asthma
- trouble urinating due to an enlarged prostate gland
- If you or your child are taking sedatives or tranquilizers
- Do not exceed recommended dosage.
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- you get nervous, dizzy, or sleepless
- if symptoms do not improve within 7 days or are accompanied by fever.
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- take every 6 hours
- do not take more than 4 doses in 24 hours or as directed by a doctor
|Adults and children 12 years of age and older||1 to 2 tablets|
|Children 6 to under 12 years of age||1/2 to 1 tablet|
|Children under 6 years of age||Ask a doctor|
store at controlled room temperature 20°-25°C (68°-77°F)
- Tamper Evident: Do not use if seal is broken or missing.
Calcium Phosphate, Corn Starch, Citric Acid Anhydrous Powder, Di-Pac FD&C Blue #2, Magnasweet, Magnesium Stearate NF, Mannitol, Methocel E10 M cr, Neusilin Grade UFL2, Purified Water, Sodium Sacharrin, Strawberry Flavor, Talc, Zytan (galloquinate)
phenylephrine hydrochloride and diphenhydramine hydrochloride tablet, chewable
|Labeler - Pernix Therapeutics, LLC (004672296)|
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.