Diphenhydramine Hydrochloride 25mg Tablet
FDA Label NDC 70692-148
11 label sections · Submitted to the FDA by Strive Pharmaceuticals Inc · 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or 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
Warnings
Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
• 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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
• take every 4 to 6 hours, or as directed by doctor
• do not take more than 6 times in 24 hours
| adults and children 12 years and older | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years old | do not use |
Other Information
• each tablet contains: calcium 18.64 mg
• store between 20-25°C (68-77°F)
• protect from light.
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
Questions Or Comments?
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Packaging
Strive-148-1 (70692148 3)
Strive-148-2 (70692148 4)
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