CLEAR TIME- diphenhydramine hydrochloride tablet, film coated 
HyVee Inc

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.

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Hy-Vee, Inc. Clear Time ™ 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 of QlearQuil® Nighttime Allergy Relief

Clear Time™

Diphenhydramine HCl – Antihistamine

Nighttime Allergy Relief

ACTUAL SIZE

Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

24 CAPLETS

Clear Time Image 1
Clear Time Image 2
CLEAR TIME 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-119
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:42507-119-6224 in 1 CARTON02/16/201510/17/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/16/201510/17/2016
Labeler - HyVee Inc (006925671)

Revised: 11/2017
Document Id: 2ec147ae-87f7-4645-8dcb-75d4c2af9806
Set id: 9a16b92e-3921-4960-b33e-2de2d37b54ac
Version: 2
Effective Time: 20171118
 
HyVee Inc