Otc - Active Ingredient
Diphenhydramine HCl 25mg
Diphenhydramine Hydrochloride 25mg Tablet
FDA Label NDC 70692-148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc for the product Diphenhydramine Hydrochloride 25mg (NDC 70692-148). 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.
Label Section Quick Index
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Dosage & Administration
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| adults and children 12 years of age and over | take 1 to 2 caplets |
| children 6 to under 12 years | take 1 caplet |
| children under 6 years of age | do not use |
Indications & Usage
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
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold:
Warnings
Do not use
- to make a child sleepy
- 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
- 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
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
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
Antihistamine
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
- avoid excessive heat, cold and humidity
Package Label.Principal Display Panel
148 (148)
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