Careall diphenhydramine tablet, coated

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 usewith 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 youare 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

Ingredients and appearance - Product information

Careall diphenhydramine tablet, coated- Diphenhydramine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 51824-056
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
D&c red no. 27 ( UNII: 2LRS185U6K)
Hydroxymethyl cellulose ( UNII: 273FM27VK1)
Lactose ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color pink (Bright Pink) Score 1
Shape OVAL (Oval in Shape, sides straight, top and bottom rounded) Imprint Code 048;D
Size 11 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - New World Imports, Inc( 075372276)

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