Drug Facts
Active ingredient (in each tablet)
Diphenhydramine HCl 25 mg
Diphenhydramine Hydrochloride Tablet, Film Coated
FDA Label NDC 69842-981
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, Inc for the product Diphenhydramine Hydrochloride (NDC 69842-981). 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 drug facts, otc - 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, 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
Otc - Purpose
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
■ Trouble urinating due to an enlarged 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 drinks
■ Alcohol, sedatives, and 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.
Overdosage
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 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 37 mg
■ Store between 20-25° C (68-77° F). Protect from light.
Inactive Ingredient
Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Silica, Stearic Acid, Talc, Titanium Dioxide and Triacetin
Questions Or Comments?
1-800-231-4670
Other
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy LIQUIGELS®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
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1-800-SHOP CVS
Product of China
V-34601
Package Label.Principal Display Panel
CVS Health
Compare to the active ingredient in Benadryl® Allergy LIQUIGELS®*
Allergy Relief
Diphehydramine HCl, 25 mg
Antihistamine
Relief of: Sneezing; Runny nose; Itchy,watery eyes; Itchy throat
200 Tablets
* Please review the disclaimer below.
