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Diphenhydramine Hydrochloride by Bonita Pharmaceuticals LLC

Dosage form: tablet, coated
Ingredients: Diphenhydramine Hydrochloride 25mg
Labeler: Bonita Pharmaceuticals LLC
NDC Code: 53598-004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Diphenhydramine HCL 25mg Caplets

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

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53598-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (DIPHENHYDRAMINE) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite ((Coated with pink film)) Scoreno score
ShapeOVAL ((biconvex)) Size11mm
FlavorImprint CodeG17
Contains    
Packaging
#Item CodePackage Description
1NDC:53598-004-01100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/21/2013
Labeler - Bonita Pharmaceuticals LLC (004219442)
Registrant - Bonita Pharmaceuticals LLC (004219442)
Establishment
NameAddressID/FEIOperations
Bonita Pharmaceuticals LLC004219442label(53598-004)

 
Bonita Pharmaceuticals LLC

← See all Diphenhydramine Hydrochloride brands

Medically reviewed on May 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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