The following Structured Product Label (SPL) was submitted to the FDA by Belleview Biosciences for the product Diphenhydramine Hcl (NDC 84447-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, drug facts, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions: Take every 4-6 hours, or as directed by doctor. * Do NOT exceed the recommended dose
| Age | Dose |
| Adults and Children 12 years of age and over | take 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours |
| Children 6 to under 12 years of age | take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours |
| Children under 6 years of age | Consult a doctor |
Warnings:
Do not use: ■ with any other product containing
diphenhydramine, even one used on skin ■ to make a
child sleepy
Ask a doctor before use if you have: ■ a breathing
problem such as emphysema or chronic bronchitis
■ glaucoma ■ trouble urinating due to the enlarged
prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product: ■ excitability might occur,
especially in children ■ marked drowsiness may occur
■ avoid alcoholic drinks ■ alcohol, sedatives, and
tranquilizers may increase drowsiness effect ■ be careful
when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health
professional before use.
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.
Inactive Ingredients: Citric Acid,
Flavor, Methylparaben, Monoammonium
Glycyrrhizinate, Potassium Citrate, Propylene Glycol,
Propylparaben, Purified Water, Sorbitol, Sucralose
Uses: Temporarily relieves these symptoms due
to hay fever or other upper respiratory allergies: ■
runny nose ■ sneezing ■ itchy, watery eyes ■
itching of the nose or throat ■ Temporarily relieves
these symptoms due to the common cold: ■ runny
nose ■ sneezing
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.
Purpose: Antihistamine
Active Ingredient (in each 5 mL tsp)
Diphenhydramine HCL, 12.5 mg
* Please review the disclaimer below.
