ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CVS Pharmacy, Inc. Allergy Relief Drug Facts

Active ingredient (in each caplet)

Diphenhydramine hydrochloride 25 mg

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 of the common cold:
•
runny nose
•
sneezing

Warnings

Do not use

•
with any other product containing diphenhydramine, even one used on skin
•
to make a child sleepy

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

sedatives or tranquilizers

When using this product

•
marked drowsiness may occur
•
avoid alcoholic drinks
•
excitability may occur, especially in children
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
be careful when driving a motor vehicle or operating machinery

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 (1-800-222-1222).

Directions

•
take every 4 to 6 hours, not more than 6 doses in 24 hours

adults & children 12 years of age and over

1 or 2 caplets

children 6 to under 12 years of age

1 caplet

children under 6 years of age

do not use

Other information

•
each caplet contains: calcium 15 mg
•
store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in QlearQuil® Nighttime Allergy Relief

NIGHTTIME

Allergy Relief

DIPHENHYDRAMINE HCl 25 mg

Antihistamine

Relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

24 CAPLETS

Actual Size

Allergy Relief Image 1
Allergy Relief Image 2
ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-976
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint Code L431
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-976-6224 in 1 CARTON11/21/201411/28/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-976-6748 in 1 CARTON11/21/201411/28/2016
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/21/201411/28/2016
Labeler - CVS Pharmacy (062312574)

Revised: 11/2017
Document Id: 826a2ebf-28e9-44a6-86a4-02506d225b7d
Set id: f6524c77-db5c-4fe0-89b8-436eafdb4c95
Version: 3
Effective Time: 20171122
 
CVS Pharmacy