FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Hf Acquisition Co Llc, Dba Healthfirst. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg
Otc - Purpose
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
Warnings
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
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
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
excitability may occur, especially in children
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 (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 age do 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
corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Questions Or Comments
1-800-616-2471
Otc - When Using
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
Dosage & Administration
ORAL
Diphenhydramine HCl 25 mg
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
Indications & Usage
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
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