Diphenhydramine Hydrochloride - Health Pharma USA LLC

Manufacturer
Health Pharma USA LLC
Effective date
2026-06-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
weekly-update
Hydrated at
2026-07-17 21:42:02

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

Dosage and administration

Adults and children 12 years  and over: 1 or 2 caplet (s) Children 6 to under 12 years of age: 1 caplet Children under 6 years of age: do not use; Do not take more than 6 caplets a day.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

  • Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.

Warnings

WARNINGS SECTION

Do not use

  • To make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • Trouble urinating due to an enlarged prostate gland
  • Glaucoma 
  • A breathing problem such as emphysema or chronic bronchitis

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, may cause drowsy.
  • Excitability may occur, especially in children. 
  • Be careful when driving a motor vehicle or operating machinery.

Stop use and ask doctor ifsymptoms not relieved within seven days usage, please contact physician or health care provider.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years  and over:1 or 2 caplet (s)
Children 6 to under 12 years of age:1 caplet
Children under 6 years of age:do not use; Do not take more than 6 caplets a day.

Other Information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Read all product information before use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium Phosphate, Magnesium stearate, Microcrystalline Cellulose (PH-102), D&C Red 27, Titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free  1-844-832-1138

Monday through Friday 9AM- 5PM EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71679-30871679-308-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC31755678-825c-b84a-e063-6294a90a5a832026-06-27WarningsExact identifier
ndc (package): 71679-308-00
ndc (product): 71679-308
ndc11 (package): 71679030800
spl id: 5535aeab-2fdb-8e48-e063-6294a90ab610
spl set id: 31755678-825c-b84a-e063-6294a90a5a83

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.