Diphenhydramine Oral Solution

Active Ingredients: Diphenhydramine

Diphenhydramine Oral Solution is a human antihistamine medicine formulated for oral administration at a strength of 12.5mg/5ml. Diphenhydramine is a first-generation H1 antihistamine used to temporarily relieve symptoms associated with hay fever and other upper respiratory allergies, including sneezing, runny nose, itchy or watery eyes, and itching of the nose or throat. In some markets, approved labeling may also include relief of runny nose and sneezing associated with the common cold.

Diphenhydramine acts primarily as an inverse agonist at histamine H1 receptors, reducing the effects of histamine that contribute to allergic symptoms. Because it readily crosses the blood-brain barrier, it can cause sedation. It also has antimuscarinic activity, which contributes to effects such as dry mouth, blurred vision, constipation, and urinary retention.

Diphenhydramine is also used in some clinical settings for the prevention and treatment of motion sickness. Other uses, including short-term treatment of insomnia in adults, depend on the approved indication and labeling in the destination market. Diphenhydramine should not be used to make a child sleepy.

DiphyCare™ Diphenhydramine Oral Solution is produced by AdvaCare Pharma in GMP-compliant manufacturing facilities. Product specifications, labeling, packaging, and approved indications may vary according to manufacturing origin and the regulatory requirements of the destination market.

AdvaCare Pharma manufactures Diphenhydramine Oral Solution as part of its portfolio of 55+ oral liquid medicines supplied to distributors in more than 65 markets. GMP-compliant production, controlled manufacturing processes, and market-specific product configurations support consistent quality across international supply chains. Packaging, labeling, and regulatory documentation are aligned with applicable destination-market requirements.

For pharmaceutical distributors, DiphyCare™ provides an established first-generation antihistamine format in a 12.5mg/5ml oral solution, with scalable supply and access to AdvaCare Pharma's broader oral-liquid product range.

What is Diphenhydramine Oral Solution used for?

How is Diphenhydramine Oral Solution used?

This medication is a liquid for oral administration. Measure each dose using the calibrated dosing device supplied with the product or another device specifically intended for measuring liquid medicines. Do not use a household spoon.

Diphenhydramine may be taken with or without food. Follow the approved product label or the directions of a doctor or pharmacist.

What dose should be taken?

Dosage should follow the approved prescribing information or OTC labeling for the destination market. For a 12.5mg/5ml diphenhydramine oral solution, commonly referenced U.S. labeling provides the following allergy-symptom doses:

• Adults and children 12 years and over: 25-50mg (10-20ml) every 4-6 hours.
• Children 6 to under 12 years: 12.5-25mg (5-10ml) every 4-6 hours.
• Children 2 to under 6 years: use only if directed by a doctor.
• Children under 2 years: do not use.

Do not exceed 6 doses in 24 hours unless a doctor specifically directs otherwise. Dosing recommendations can vary by indication, formulation, age group, and national product authorization. Always follow the locally approved product information.

As with all pharmaceuticals, unwanted effects can occur with Diphenhydramine Oral Solution.

Excitability or paradoxical stimulation may occur, particularly in children.

Diphenhydramine has anticholinergic and sedative effects. Older adults may be more susceptible to confusion, dizziness, urinary retention, falls, and other adverse effects and should use diphenhydramine only on the advice of a healthcare professional.

Overdose can cause serious neurological, anticholinergic, and cardiac toxicity. If an overdose is suspected, seek emergency medical assistance immediately.

For a comprehensive understanding of potential side effects and contraindications, consult the approved product information and a qualified medical professional.

Diphenhydramine can cause marked drowsiness and may impair alertness. Do not drive, operate machinery, or perform activities requiring full attention until you know how the medicine affects you. Alcohol, sedatives, tranquilizers, and other central nervous system depressants can increase drowsiness.

Before treatment, tell a doctor or pharmacist about all prescription medicines, nonprescription medicines, vitamins, supplements, and herbal products being used. Particular caution is required with medicines that have sedative or anticholinergic effects.

If pregnant or breastfeeding, consult a healthcare professional before use.

In children, excitability or paradoxical stimulation may occur. Do not use diphenhydramine in children under 2 years of age. For children aged 2 to under 6 years, use only if directed by a doctor and in accordance with the approved local label.

Diphenhydramine may interfere with allergy skin testing. A healthcare professional should advise whether the medicine needs to be stopped before testing.

Diphenhydramine HCl 12.5mg is used due to its effectual balance between alleviating allergy symptoms and minimizing drowsiness. This dosage is ideal for pediatric patients and those requiring mild symptom relief, as it provides sufficient antihistamine action while reducing the risk of sedation.