Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 25 mg
Allergy Relief Tablet, Chewable
FDA Label NDC 69842-685
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Allergy Relief (NDC 69842-685). 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 chewable 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:
- sneezing
- runny nose
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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- 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, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| adults and children 12 years and over | 1 to 2 chewable tablets |
| children 6 to under 12 years | 1 chewable tablet |
| children under 6 years | do not use |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C blue #1 aluminum lake, flavor, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, stearic acid, sucralose
Questions Or Comments?
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Compare to the active ingredient in Benadryl®*
Chewable Tablets
Allergy Relief
DIPHENHYDRAMINE
HYDROCHLORIDE, 25 mg
Antihistamine
Relief of:
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat
For Ages 6 Years & Over
18 CHEWABLE TABLETS
Actual Size
Grape Flavored
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DO NOT USE IF INDIVIDUAL BLISTER UNITS ARE BROKEN OR OPEN.
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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CVS.com® 1-800-SHOP CVS
V-18615
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50844 ORG041868544
Cvs 44-685 (Cvs 44 685 Allergy 1)
* Please review the disclaimer below.
