TOPCARE CLEAR TIME- diphenhydramine hydrochloride tablet, film coated 
Topco Associates LLC

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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Topco Associates LLC. 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?

1-888-423-0139

Package/Label Principal Display Panel

NIGHTTIME ALLERGY RELIEF

Clear Time™

DIPHENHYDRAMINE HCl 25 mg

ANTIHISTAMINE

Sneezing

Runny nose

Itchy, watery eyes

Itchy nose or throat

COMPARE TO QLEARQUIL® NIGHTTIME ALLERGY RELIEF active ingredient

actual size

24 CAPLETS

Topcare Clear Time Image 1

Topcare Clear Time Image 2

TOPCARE CLEAR TIME 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-480
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:36800-480-6224 in 1 CARTON01/14/201512/12/2017
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 finalpart34101/14/201512/12/2017
Labeler - Topco Associates LLC (006935977)

Revised: 11/2017
 
Topco Associates LLC