Label: DIPHENHYDRAMINE HYDROCHLORIDE solution

  • NDC Code(s): 83720-502-04, 83720-502-16
  • Packager: Oncor Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2025

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  • ACTIVE INGREDIENT
    Active ingredients (in each 5 mL teaspoonful)                  Purpose - Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine
  • Uses
    - sneezing - - runny nose - - itchy, watery eyes - - itching of the nose or throat - - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • 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 - - trouble urinating due to an enlarged 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 - - be careful when driving a motor vehicle or operating machinery - ...
  • If pregnant or breast-feeding,
    ask a health professional before use.
  • Directions
    - take every 4 to 6 hours or as directed by a doctor - - do not take more then directed - - mL=milliliter - - find right dose on chart below -  Children under 2 years Do not use -  Children 2 to 5 ...
  • Inactive ingredients
    citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.
  • Other information
    - each 1 tsp (5mL) contains: sodium 4 mg - - store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]. Protect from freezing. - tamper evident by foil seal under cap. Do not use if foil ...
  • KEEP OUT OF REACH OF CHILDREN
    Keep out of reach of children.
  • OVERDOSAGE
    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
  • Questions?
    You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.
  • SPL UNCLASSIFIED SECTION
  • Principal Display Panel
    Oncor Pharmaceuticals - NDC 83720-502-16 - Diphenhydramine Hydrochloride - Oral Solution - 12.5 mg/5 ml - Antihistamine - Cherry Flavor - RELIEVES - - Sneezing - - Itchy, Watery Eyes - - Runny Nose - ...
  • PRINCIPAL DISPLAY PANEL
    Diphenhydramine (16 oz) ...
  • INGREDIENTS AND APPEARANCE
    Product Information