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.
Active ingredient(in each capsule)
Diphenhydramine HCL 25 mg
Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
Itchy, watery eyes.
Do not use
With any other product containing Diphenhydramine HCL, including one applied topically.
Ask a doctor or pharmacist before use
If you have
Trouble urinating due to enlarged prostate gland
A breathing problem such as emphysema or chronic bronchitis
If you are taking sedatives or tranquilizers
When using this product
Avoid alcoholic drinks.
Marked drowsiness may occur.
Excitability may occur, especially in children.
Alcohol, sedatives and tranquilizers may
careful when driving a motor vehicle or operating machinery.
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.
Take every 4-6 hours
Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over
1 to 2 capsule
Children 6 to under 12 years
Children under 6 years
ask a doctor
Store at room temperature 15-30 degrees C (59-86 degrees F)
Protect from excessive moisture
Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate
diphenhydramine hcl capsule
HUMAN OTC DRUG
Item Code (Source)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
SODIUM LAURYL SULFATE
15 CAPSULE in 1 BOTTLE, PLASTIC
20 CAPSULE in 1 BOTTLE, PLASTIC
30 CAPSULE in 1 BOTTLE, PLASTIC
60 CAPSULE in 1 BOTTLE, PLASTIC
90 CAPSULE in 1 BOTTLE, PLASTIC
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph final
Labeler - NuCare Pharmaceuticals, Inc.
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