CAREALL DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, coated

CAREALL Diphenhydramine by

Drug Labeling and Warnings

CAREALL Diphenhydramine by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, coated

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
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
Color	pink (Bright Pink)	Score	no score
Shape	OVAL (Oval in Shape, sides straight, top and bottom rounded)	Size	11mm
Flavor		Imprint Code	048;D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-056-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/28/2016

Labeler - New World Imports, Inc (075372276)