DIPHENHYDRAMINE HYDROCHLORIDE tablet, coated

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Bonita Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each Caplet)

Diphenhydramine HCl 25 mg

Purposes

Antihistamine

Uses

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

• runny nose
• itchy, watery eyes
• itching of the nose and throat
• sneezing

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin.
• to make a child sleepy.

Ask a doctor before use if you have

• glaucoma
• difficulty in urinating due to an enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness effect
• use caution 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.

Keep out of reach of children.

In case of overdose,

get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• take every 4 to 6 hours as needed
• do not take more than 6 times in 24 hours or as directed by a doctor

Adults and children 12 years and older

• 1 or 2 caplets (25mg to 50mg)

Children under 12years

• ask a doctor

Other Information

• Store at room temperature
• keep lid tightly closed in dry place
• Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate Dihydrate, Hydroxypropyle MethylCellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silica, Stearic Acid and Titanium Dioxide.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53598-004
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)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white ((Coated with pink film))	Score	no score
Shape	OVAL ((biconvex))	Size	11mm
Flavor		Imprint Code	G17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53598-004-01	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/21/2013

Labeler - Bonita Pharmaceuticals LLC (004219442)

Registrant - Bonita Pharmaceuticals LLC (004219442)

Establishment
Name	Address	ID/FEI	Business Operations
Bonita Pharmaceuticals LLC		004219442	label(53598-004)