Active Ingredient (In Each Banded Capsule)
Diphenhydramine Hydrochloride 25 mg
Antihistamine Capsule
FDA Label NDC 77333-227
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Antihistamine (NDC 77333-227). 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 active ingredient (in each banded capsule), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy.
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution 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.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
- take every 4 to 6 hours or as directed by a doctor
- do not take exceed 6 doses in 24 hours
- adults and children 12 years and older: 1 capsule to 2 capsules
- children 6 to under 12 years: 1 capsule
- children under 6 years: do not use this product in children under 6 years of age
Other Information
- store at 20° - 25°C (68°-77°F)
Inactive Ingredients
butylparaben, corn starch, D&C Red #28, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide
Questions Or Comments?
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