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1113-DDM-2021-1126


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg


Purpose

Antihistamine


Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat
  • temporarily relieves these symptoms due to the common cold: runny nosesneezing

Warnings


OTC - DO NOT USE SECTION

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 breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

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
  • 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

adults and children 12 years of age and over25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age12.5 mg 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules. to 25 mg (1 capsule)
children under 6 years of ageask a doctor
  • take every 4 to 6 hours
  • do not exceed 6 doses in 24 hours

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • protect from moisture
  • retain carton for complete product information

Inactive ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate