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Drug Facts


Drug Facts

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg


OTC - PURPOSE SECTION

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


OTC - DO NOT USE SECTION

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin


OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have  a breathing problem such as emphysema or chronic bronchitis

 glaucoma  trouble urinating due to an enlarged prostate gland


OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


OTC - WHEN USING SECTION

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

 excitability may occur, especially in children


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.


OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children 12 years of age and over 1 to 2 capsules
children 6 to under 12 years of age 1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

Other information

 store in a dry place at 15° – 30°C (59° – 86°F)


INACTIVE INGREDIENT SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate


SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.


HOW SUPPLIED SECTION

HOW SUPPLIED: Diphenhydramine HCL capsules are available as follows:

NDC 72789-317-10 Bottles of 10

NDC 72789-317-12 Bottles of 12

NDC 72789-317-15 Bottles of 15

NDC 72789-317-20 Bottles of 20

NDC 72789-317-30 Bottles of 30


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL