Banophen Capsule
FDA Label NDC 0904-7672
11 label sections · Submitted to the FDA by Major Pharmaceuticals · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Banophen (NDC 0904-7672). 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 capsule), 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 Capsule)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
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
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 (1-800-222-1222). 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 a doctor • do not take more than 6 times in 24 hours
| adults and children 12 years of age and older | 1 to 2 capsules |
| children 6 to under 12 years of age | 1 capsule |
| children under 6 years of age | do not use |
Other Information
• store at 20–25°C (68–77°F)
• protect from light, heat and moisture
Inactive Ingredients
butylparaben, corn starch, D&C red no. 28, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, purified water
Questions Or Comments?
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Packaging
Banophentm-1 (09047672 4)
Banophentm-2 (09047672 5)
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