CAREALL DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, coated 
New World Imports, Inc

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Drug Facts

Active Ingredient

 Diphenhydramine HCl 25mg

Purpose

Antihistamine

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat

Temporarily relieves these symptoms associated with the common cold:

Sneezing, runny nose

Warnings

Do not use with any other products containing diphenhydramine, including ones 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 beverages

Alcohol, sedatives, and tranquilizers may increase drowsiness

Be careful 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

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 of age and older: 1 to 2 caplets

Children 6 to 12 years: 1 caplet

Children under 6: do not use

Inactive Ingredients

croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

DHC25 Label
CAREALL DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-056
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Colorpink (Bright Pink) Scoreno score
ShapeOVAL (Oval in Shape, sides straight, top and bottom rounded) Size11mm
FlavorImprint Code 048;D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-056-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201612/01/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/28/201612/01/2026
Labeler - New World Imports, Inc (075372276)

Revised: 12/2023
Document Id: 62aeb97c-6967-4e5a-94ae-1b12f5de0199
Set id: f3b177ef-55d5-4525-bf33-99205c414a5b
Version: 4
Effective Time: 20231211
 
New World Imports, Inc