Diphenhydramine HCl Oral Solution
Diphenhydramine HCl Oral Solution is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE manufactured by Natco Pharma USA LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231101.
- Generic name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Natco Pharma USA LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69339-151
- Application
- M012
- Label effective
- 20231101
Active ingredients
Indications & Usage
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat
Dosage & Administration
Directions • Use the following dosage guidelines when using this product Age (yr) Dose (mL) Adults and children 12 years and older take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours. Children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours Children under 6 years ask a doctor
Contraindications
Not available.
Warnings
Warnings Do not use • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Adverse Reactions
Not available.