Dosage form: tablet, multilayer
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: Capellon Pharmaceuticals, LLC
NDC Code: 64543-026
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.
Diphenhydramine Hydrochloride 50 mg
Pseudoephedrine Hydrochloride 60 mg
Diphenhydramine Hydrochloride Antihistamine / Antitussive
Pseudoephedrine Hydrochloride Nasal Decongestant
For the temporary relief of
- cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
- runny nose
- itching of the nose or throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies
- nasal congestion
- clear nasal passages
- shrink swollen membranes
- Do not exceed recommended dosage
- May cause excitability especially in children
- May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.
- Avoid alcoholic beverages
- Use caution when driving a motor vehicle or operating machinery.
- with any other product containing diphenhydramine, even one used on skin
- If you have a breathing problem such as emphysema or chronic bronchitis
- 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 nervousness, dizziness, or sleeplessness occur.
- A persistent cough may be a sign of a serious condition. If cough or other symptoms do not improve within 7 days, tend to recur, or are accompanied by fever, rash, or persistent headache, consult a doctor.
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- a persistent or chronic cough or breathing problem such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
- before taking this product if you are taking sedatives or tranquilizers
Ask a health professional before use.
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
- Adults (12 and older): One tablet every 4 to 6 hours. Not to exceed 4 doses in 24 hours.
- Children under 12 years of age: Consult a physician.[/S]
store at 20°-25°C (68°-77°F)
colloidal silicon dioxide, crospovidone polyplasdone, D&C Yellow #10, Green LKB #LB-620, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone
Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 pm CST)
diphenhydramine hcl and pseudoephedrine hcl tablet, multilayer
|Labeler - Capellon Pharmaceuticals, LLC (124568093)|
|Registrant - Capellon Pharmaceuticals, LLC (124568093)|
|Sovereign Pharmaceuticals, LLC||623168267||MANUFACTURE(64543-026)|
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.