DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, coated

Diphenhydramine by

Drug Labeling and Warnings

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 immediately.

INDICATIONS & USAGE

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 one applied topically

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

DOSAGE & ADMINISTRATION

Take every 4 to 6 hours

Do not take more than 6 doses 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: Consult a doctor

INACTIVE INGREDIENT

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE  
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-048
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 (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	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: 51824-048-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2010	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/09/2010	08/01/2020

Labeler - New World Imports, Inc (075372276)