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Plus Pharma by Gemini Pharmaceuticals, Inc. dba Plus Pharma

Medically reviewed on February 19, 2018

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Gemini Pharmaceuticals, Inc. dba Plus Pharma
NDC Code: 51645-745

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 25 mg

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

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

Ask a doctor before use if you have
  • glaucoma
  • difficulty in urination due to 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 the 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 12 caplets in 24 hours or as directed by a doctor
  • Adults and children 12 years and older 1 or 2 caplets (25 mg to 50 mg)
  • Children under 12 years consult a doctor

Other information
  • each caplet contains: calcium 15 mg
  • Store at room temperature
  • Keep lid tightly closed in a dry place

Inactive ingredients

Croscarmellose sodium, D&C red #27, dicalcium phosphate dihydrate, hypromellose, 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 (800) 795-9775.

Do not use if imprinted safety seal under cap is broken or missing

Distributed by: Plus Pharma, Commack, NY 11725

NDC 51645-745-01

PlusPHARMA

Diphenhydramine 25 mg

(Diphenhydramine HCl)

Antihistamine

Allergy Relief for:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose & Throat

Compare to the active ingredient in BENADRYL® Allergy Tablets*

*Plus Pharma is not affiliated with the owner of the registered trademark Benadryl®.

100 CAPLETS 25 mg each

PLUS PHARMA 
diphenhydramine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-745
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 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
PROPYLENE GLYCOL 
STEARIC ACID 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULE (Biconvex Caplets) Size3mm
FlavorImprint CodeG17
Contains    
Packaging
#Item CodePackage Description
1NDC:51645-745-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/12/2015
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIOperations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(51645-745)

 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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Further information

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

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