Otc - Active Ingredient
Diphenhydramine HCl 25mg
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc for the product Diphenhydramine Hydrochloride 25mg (NDC 70692-111). 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 otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Diphenhydramine HCl 25mg
croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethyl;ene glycol, talc, titanium dioxide
| adults and children 12 years of age and over | 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years of age | do not use |
for relief of occasional sleeplessness
Do not use
Ask a doctor before use if you have
Ask a doctor or a pharmacist before use if
you are taking sedatives or tranquilzers
When using this product
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Nighttime sleep-aid
* Please review the disclaimer below.