Active Ingredients (In Each Banded Capsule)
Diphenhydramine HCl 25 mg
Allergy Relief Capsule
FDA Label NDC 46122-440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Allergy Relief (NDC 46122-440). 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 ingredients (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
- 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
- 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 (1-800-222-1222) right away.
Directions
- take every 4 to 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- see end flap for expiration date and lot number
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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Compare to Benadryl® active ingredients*
NDC 46122-440-78
Allergy Relief
diphenhydramine HCl 25 mg
Antihistamine
Relief of:
• Sneezing • Runny Nose
• Itchy Throat • Itchy, Watery eyes
100 Capsules ι 25 mg Each
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL
UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND
CAPSULE IS BROKEN OR MISSING
*This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of
the registered trademark Benadryl®.
50844 ORG101619012
Distributed by
AmerisourceBergen
1300 Morris Drive
Chesterbrook PA 19087
Questions or Concerns?
www.mygnp.com
Good Neighbor Pharmacist Brand Products
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