FDA Label for Diphenhydramine Hydrochloride 25mg
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride 25mg Product Label
The following document was submitted to the FDA by the labeler of this product Strive Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Diphenhydramine HCl 25mg
Inactive Ingredient
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
Dosage & Administration
- take with a full glass of water
- do not take more than directed
| 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 |
Indications & Usage
for relief of occasional sleeplessness
Warnings
Do not use
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostrate gland
- avoid alcoholic drinks
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
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.
Otc - Keep Out Of Reach Of Children
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.
Otc - Purpose
Nighttime sleep-aid
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
- avoid high humidity
- protect from light
Package Label.Principal Display Panel
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