Label: DIPHENHIST- diphenhydramine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 20, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active ingredient (in each 5mL teaspoonful)
    Diphenhydramine HCl USP 12.5 mg
  • Purpose
    Antihistamine
  • Uses
    temporarily relieves these symptoms of hay fever or other upper respiratory allergies - runny nose - sneezing - itchy, water eyes - itchy nose or throat
  • Warnings
    Do not use with 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 ...
  • Directions
    take every 4 – 6 hours - do not take more than 6 doses in 24 hours - adults and children 12 years and over2 - 4 teaspoonfuls - children 6 to under 12 years1 - 2 teaspoonfuls - children under ...
  • Other information
    each teaspoonful (5 mL) contains: sodium 5 mg - store between 20°-25° C (68°-77°F) protect from light. Store in outer carton until contents used
  • Inactive ingredients
    artificial cherry flavor, citric acid, D&C red #33, FD&C red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution
  • Questions or comments?
    call 1-800-645-2158, 9 am - 5pm ET, Monday - Friday
  • PRINCIPAL DISPLAY PANEL
    COMPARE TO - ACTIVE INGREDIENT IN - BENADRYL® ALLERGY LIQUID* CHILDREN'S ALCOHOL-FREE - ALLERGY MEDICATION - Diphenhist® ORAL SOLUTION - Diphenydramine HCI, USP - Antihistamine - For Temporary ...
  • INGREDIENTS AND APPEARANCE
    Product Information