25034563-6422-daf6-e063-6394a90af980
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each capsule) Diphenhydramine HCl 25 mg
Medication Information
Warnings and Precautions
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).
Indications and 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
Dosage and 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
Description
Active ingredient (in each capsule) Diphenhydramine HCl 25 mg
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
Section 50565-1
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.
Section 50567-7
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
Section 51727-6
corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
Section 51945-4
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Antihistamine
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
Drug Facts
Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg
Other Information
store in a dry place at 15° – 30°C (59° – 86°F)
Questions Or Comments
1-800-616-2471
Structured Label Content
Uses (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
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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).
Section 50565-1 (50565-1)
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.
Section 50567-7 (50567-7)
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
Section 51727-6 (51727-6)
corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Antihistamine
Directions (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
Drug Facts (DRUG FACTS)
Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg
Other Information (OTHER INFORMATION)
store in a dry place at 15° – 30°C (59° – 86°F)
Questions Or Comments (QUESTIONS OR COMMENTS)
1-800-616-2471
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:55.707556 · Updated: 2026-03-14T23:04:16.644897