Assured Night time Cold and Cough
Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 6.25mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Bio-Pharm, Inc.
NDC Code: 59741-202
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.
Cold & Cough
|Active Ingredients (in each TSP (5 mL))||Purposes|
|Diphenhydramine HCL 6.25 mg||Antihistamine/cough suppressant|
|Phenylephrine HCL 2.5 mg||Nasal decongestant|
- itchy nose or throat
- runny nose
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with cold
- in a child under 4 years of age
- in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- with any other product containing diphenhydramine, even one used on skin
- for the purpose of making your child sleepy
- heart disease
- high blood pressure
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- a breathing problem such as chronic bronchitis
taking sedatives or tranquilizers
- do not exceed recommended dosage
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.
These could be signs of a serious condition
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor
|Children under 4 years of age||Do not use|
|Children 4 to under 6 years of age||Do not use unless directed by doctor|
|Children 6 to under 12 years of age||2 TSP (10 mL)|
- each TSP contains: sodium 9 mg
- store at 20°-25°C (68°-77°F)
- TAMPER EVIDENT: Do no use if foil seal over mouth of the bottle is torn, broken or missing.
benzoic acid, citric acid anhydrous, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol
Levittown, PA 19057
|ASSURED NIGHT TIME COLD AND COUGH
diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
|Labeler - Bio-Pharm, Inc. (801652546)|
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.