Allergy Relief
a73d20df-3df7-42f7-8c88-93fee7e9ccec
HUMAN OTC DRUG LABEL
Sep 17, 2025
HealthLife of USA LLC
DUNS: 079656178
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL-1000 Caplets
INDICATIONS & USAGE SECTION
Uses:
- Temporarily relieves Sneezing, runny nose, itchy, watery eyes, and itchy throat.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
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.
DOSAGE & ADMINISTRATION SECTION
Directions
**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.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use
- 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
- Trouble urinating due to an enlarged prostate gland
- Glaucoma
- A breathing problem such as emphysema or chronic bronchitis
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, may cause drowsy.
- Excitability may occur, especially in children.
- Be careful when driving a motor vehicle or operating machinery.
OTC - STOP USE SECTION
Stop use and ask doctor if
symptoms not relieved within seven days usage, please contact physician or health care provider.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use
OTHER SAFETY INFORMATION
Other Information
- Store at controlled room temperature 20°-25°C (68°-77°F).
- Read all product information before use.
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Colloidal silicon Dioxide, Croscarmellose sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), D&C Red 27, Titanium dioxide.
OTC - QUESTIONS SECTION
Questions or comments?
Call toll free 1-844-832-1138
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