Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Aller-ben Tablet, Film Coated
FDA Label NDC 68196-829
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sam's West Inc for the product Aller-ben (NDC 68196-829). 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 tablet), 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
- itchy, watery eyes
- sneezing
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the 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 beverages
- 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 overdose, get medical help or contact a Poison Control Center right away.
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 and over | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | do not use |
Other Information
- each tablet contains: calcium 30 mg
- protect from moisture
- use by expiration date on package
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
Compare to Benadryl® Allergy
Ultratab® active ingredient*
NDC 68196-829-78
Member's Mark™
Aller-Ben™
Diphenhydramine HCl 25 mg
Antihistamine
Allergy
For Allergy Relief of
• Sneezing • Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
actual
size
600
Tablets
Comments or Questions?
Call 1-800-426-9391
from 8:30 a.m. to 4:00 p.m. ET
Monday - Friday
TAMPER EVIDENT: DO NOT USE IS IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Johnson
& Johnson Corporation, owner of the registered trademark
Benadryl® Allergy Ultratab®. 50844 ORG101632978
DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716
Members Mark 44-329 Aller-ben (Members Mark 44 329 Aller Ben 1)
* Please review the disclaimer below.
