Drug Facts
Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg
Diphenhydramine Hydrochloride Capsule
FDA Label NDC 72789-317
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pd-rx Pharmaceuticals, Inc. for the product Diphenhydramine Hydrochloride (NDC 72789-317). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Do Not Use
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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
Questions Or Comments?
1-800-616-2471
Other
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.
How Supplied
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
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