FDA records indicate that there are no current recalls for this drug.
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Diphenhydramine Hydrochloride Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
- trouble urinating due to enlarged prostate
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Diphenhydramine Hydrochloride Solution Manufacturers
- Ahold U.s.a., Inc,
Diphenhydramine Hydrochloride Solution | Ahold U.s.a., Inc,
take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours not to exceed 300 mg in 24 hours mL = milliliter
Age (yr)
Dose (mL)
Adult and children 12 years and older
10 mL to 20 mL
Children under 12 years
Consult a doctorAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Fred’s, Inc.
Diphenhydramine Hydrochloride Solution | Fred's, Inc.
take only one dose per day (24 hours) - see Overdose warning use dose cup mL = milliliter
adults & children 12 yrs and over
One Dose = 30 mL at bed time if needed or as directed by a doctorOther information
each 30 mL dose contains: sodium 23 mg store at room temperature protect from light. Does not meet USP <671>. - Aurohealth Llc
Diphenhydramine Hydrochloride Solution | Sun Pharma Global Fze
For Reduction of Cumulative Renal Toxicity with Chemotherapy: The recommended starting dose of Amifostine for injection is 910 mg/m2 administered once daily as a 15-minute i.v. infusion, starting 30 minutes prior to chemotherapy.
The 15-minute infusion is better tolerated than more extended infusions. Further reductions in infusion times for chemotherapy regimens have not been systematically investigated.
Patients should be adequately hydrated prior to Amifostine for injection infusion and kept in a supine position during the infusion. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated.
The infusion of Amifostine for injection should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below:
Guideline for Interrupting Amifostine for injection Infusion Due to Decrease in Systolic Blood Pressure Baseline Systolic Blood Pressure (mm Hg)
< 100
100 to 119
120 to 139
140 to 179
≥180
Decrease in systolic blood pressure during infusion of Amifostine for injection(mm Hg)
20
25
30
40
50
If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose of Amifostine for injection may be administered. If the full dose of Amifostine for injection cannot be administered, the dose of Amifostine for injection for subsequent chemotherapy cycles should be 740 mg/m2.
It is recommended that antiemetic medication, including dexamethasone 20 mg i.v. and a serotonin 5HT3 receptor antagonist, be administered prior to and in conjunction with Amifostine for injection. Additional antiemetics may be required based on the chemotherapy drugs administered.
Reconstitution
Amifostine for Injection is supplied as a sterile powder requiring reconstitution for intravenous infusion. Each single-use vial contains 500 mg of amifostine on the anhydrous basis.
Prior to intravenous injection, Amifostine for injection is reconstituted with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution (500 mg amifostine/10 mL) is chemically stable for up to 5 hours at room temperature (approximately 25°C) or up to 24 hours under refrigeration (2°C to 8°C).
Amifostine for injection prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/mL to 40 mg/mL is chemically stable for up to 5 hours when stored at room temperature (approximately 25°C) or up to 24 hours when stored under refrigeration (2°C to 8°C). CAUTION: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if cloudiness or precipitate is observed.
Incompatibilities
The compatibility of Amifostine for injection with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.
- Aurohealth Llc
Diphenhydramine Hydrochloride Solution | Aurohealth Llc
take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours not to exceed 300 mg in 24 hours mL = milliliter
Age (yr)
Dose (mL)
Adult and children 12 years and older
10 mL to 20 mL
Children under 12 years
Consult a doctorAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Pharmaceutical Associates, Inc.
Diphenhydramine Hydrochloride Solution | Pharmaceutical Associates, Inc.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours.
Adults25 to 50 mg three or four times daily. The nighttime sleep-aid dosage is 50 mg at bedtime.
Pediatric Patients, other than premature infants and neonates12.5 to 25 mg three or four times daily. Maximum daily dosage not to exceed 300 mg. For physicians who wish to calculate the dose on the basis of body weight or surface area, the recommended dosage is 5 mg/kg/24 hours or 150 mg/m2/24 hours.
Data are not available on the use of diphenhydramine hydrochloride as a nighttime sleep-aid in children under 12 years.
The basis for determining the most effective dosage regimen will be the response of the patient to medication and the condition under treatment.
In motion sickness, full dosage is recommended for prophylactic use, the first dose to be given 30 minutes before exposure to motion and similar doses before meals and upon retiring for the duration of exposure.
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