CAREALL ALLERGY RELIEF- 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

Warnings

Do not use

with any other products containing diphenhydramine, including ones used on skin

to make children sleepy

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 51824-102-01 Label
CAREALL ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-102
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 Capsule) Size12mm
FlavorImprint Code 048
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-102-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/06/2023
Labeler - New World Imports, Inc (075372276)

Revised: 12/2023
Document Id: 1c52b496-e4b7-4f0b-a3e1-a494041f7466
Set id: af2f8389-d696-4060-8abd-6eda04e73009
Version: 1
Effective Time: 20231206
 
New World Imports, Inc