Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDIPHENHYDRAMINE HCL
Labeler / manufacturerMajor Pharmaceuticals
RouteORAL
Drug classDrug class not supplied in source label
Product NDC0904-6985
Label effective date2026-08-28
Official product label reference
Diphenhydramine HCl — Major Pharmaceuticals
This page contains 14 source sections for DIPHENHYDRAMINE HCL, oral route. Label set 93753885-6add-462c-9df8-b0a1b9ce36c9, version 15.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itching of the nose or throat runny nose sneezing itchy, watery eyes
Purpose
Purpose Antihistamine
Dosage and administration — label text
Directions do not take more than directed do not take more than 6 doses in 24 hours mL = milliliter find right dose on chart below take every 4 to 6 hours, or as directed by a doctor Age Dose adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg) children 6 to 11 years 1 - 2 teaspoonsful (12.5 mg to 25 mg) children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use
Table text from source:
| Age | Dose
| adults and children 12 years and over | 2 - 4 teaspoonsful (25 mg to 50 mg)
| children 6 to 11 years | 1 - 2 teaspoonsful (12.5 mg to 25 mg)
| children 2 to 5 years | do not use unless directed by a doctor
| children under 2 years | do not use
Warnings
Warnings 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 a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the 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 beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery 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.
Active ingredient
Active ingredient (in each teaspoonful (5 mL)) Diphenhydramine HCl 12.5 mg
Do not use
Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use
Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
While using this medicine
When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage and handling
Other information each teaspoonful (5 mL) contains: sodium 4 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Inactive ingredient
Inactive ingredients anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.