Active Ingredient (In Each Capsule)
Diphenhydramine HCL 25 mg
Diphenhydramine Hcl 25 Mg Capsule
FDA Label NDC 69618-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Diphenhydramine Hcl 25 Mg (NDC 69618-024). 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 capsule), purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy 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 releaves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- itchy nose or throat
- sneezing
- itchy, watery eyes
Warnings
Do not use
- with any otherprodcut containing diphenhydramine, even one use on skin
- to make a child sleepy
Otc - Ask Doctor
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharamcist before use if you are taking sedatives or tranquilizers
Drug Facts continued of back of label
Otc - When Using
When using this product
- you may get very drowsy
- avoid alcoholic drinks
- alcohol, sedatives, & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4-6 hours
- do not take more than 6 doses in 24 hours
| adults and children 12 years and over | 1 to 2 capsules |
| children 6 to under 12 years | 1 capsule |
| children under 6 years | do not use |
Other Information
- store at room temperature
- protect from moisture
Inactive Ingredients
benzl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methlyparaben, polysorbate 80, propylparaben, sodium lauryl sulfate
Questions Or Comments?
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING
Distributed by: Reliable 1 Laboratories LLC
Valley Stream, NY 11580
Drug Facts
Package Label.Principal Display Panel
NDC 69618-024-01
Diphenhydramine HCL 25 mg
ANTIHISTAMINE
100 CAPSULES
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