DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl tablet 
Medline Industries, LP

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.

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990 Diphenhydramine HCL 25mg

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
  • sneezing
  • itchy nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • 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

  • 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
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take every 4 to 6 hours or as directed by a doctor
    • do not take more than 6 doses in 24 hours
      adults and children 12 years of age and over1 or 2 caplets
      children 6 to under 12 years1 caplet
      children under 6 yearsdo not use this product for children under 6 years of age

Other information

  • each caplet contains: calcium 25 mg
  • store between 20°-25°C (68°-77°F)
  • protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Questions or comments?

Call toll free 1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST

Package Label

label frontlabel back

DIPHENHYDRAMINE HCL 25 MG 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-990
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorpinkScorescore with uneven pieces
ShapeCAPSULESize10mm
FlavorImprint Code T;061
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-990-30100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/201806/30/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/10/201806/30/2022
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 10/2022
Document Id: ea26da62-3255-4f1a-e053-2a95a90a3400
Set id: 6bde8f0a-a388-77a7-e053-2a91aa0a04b4
Version: 5
Effective Time: 20221003
 
Medline Industries, LP