diphenhydramine hydrochloride
diphenhydramine hydrochloride is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE manufactured by Simpex Pharma Pvt. Ltd 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 20231129.
- Generic name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Simpex Pharma Pvt. Ltd
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 76457-002
- Application
- M012
- Label effective
- 20231129
Active ingredients
Indications & Usage
Uses temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract runny nose sneezing Itchy watery eyes Itching of the nose or throat.
Dosage & Administration
Directions: take every 4 to 6 hours do not take more than 6 does in 24 hours Adult and children 12 years of age and over - 1 to 2 tablet Children 6 to 12 years of age - 1 tablet Children 6 years of age - do not use this product in children under 6 years
Contraindications
Not available.
Warnings
Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin. Consult your doctor if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland. Consult your doctor if you are taking sedatives or tranquilizers sedative, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur especially in children. If Pregnant or breast-feeding, ask a health professional before use. Keep out or reach of children. In case of overdose, get medical help or contact a poison control center right away. When using this product marked drowsiness may occur avoid alcoholic drinks.
Adverse Reactions
Not available.