Allergy relief tablet, coated

Spl unclassified section

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

Otc - do not use section

Do not usewith any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

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
  • do not exceed 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age 12.5 mg to 25 mg (1 tablet)
children under 6 years of age ask a doctor

Other information

  • each tablet contains: calcium 45 mg
  • store at room temperature 15-30C (59-86F)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Ingredients and appearance - Product information

Allergy relief tablet, coated- Diphenhydramine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63868-492
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
D&c red no. 27 ( UNII: 2LRS185U6K)
Calcium phosphate, dibasic, anhydrous ( UNII: L11K75P92J)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color pink Score 1
Shape OVAL Size 11 mm
Imprint Code 25;052

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Chain Drug Marketing Association( 011920774)

Principal display panel

NDC 63868-492-24

QUALITY CHOICE

Compare to Active Ingredient in BENADRYL® Allergy

Allergy Relief

Antihistamine

Diphenhydramine HCl, 25 mg

For Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 Tablets

12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.