Diphenhydramine hydrochloride 12.5 mg/5mL Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...
Read the full MedlinePlus article ↗- Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
- What exactly does diphenhydramine treat?
- Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
- It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII A4WO0626T5
A natural aromatic oil extracted from cinnamon bark, used as a flavoring agent to improve taste and add spice notes to medicines.
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UNII SR60A3XG0F
Cinnamal is a fragrant organic compound derived from cinnamon oil. It's used in medicines as a flavoring agent and fragrance to make the product taste or smell more pleasant.
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UNII S92U8SQ71V
A natural oil extracted from cinnamon leaves used as a flavoring agent and fragrance in medicines. It provides taste and aroma to make the product more pleasant to take.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII 9DBA0SBB0L
A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
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UNII 3T8H1794QW
Eugenol is a natural oil extracted from clove and other plants. It's used in medicines as a flavoring agent and to provide a mild anesthetic effect in topical products, particularly in dental formulations.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Childrens Allergy 12.5 mg/5mL 63868-0370-04 | QUALITY | 1 bottle | $0.016 | — | FDA listed | — |
| Diphenhydramine Oral Liquid 12.5 mg/5mL 57237-0305-12 | Rising | 118 ml | $0.020 | — | Availability likely | — |
| M-Dryl 12.5 mg/5mL 58657-0528-04 | Method | 120 ml | $0.020 | — | Availability likely | — |
| foster and thrive childrens allergy relief 12.5 mg/5mL 70677-1268-01 | Strategic | 1 bottle | $0.020 | — | Availability likely | — |
| Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 24385-0379-26 | Amerisource | 1 bottle | $0.020 | — | Availability likely | — |
| CVS Health Childrens Allergy Relief 12.5 mg/5mL 59779-0793-10 | CVS | 10 vials | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 53942-0505-24 | DeMoulas | 118 ml | — | — | FDA listed | — |
| Diphenhydramine HCl Oral Solution 12.5 mg/5mL 69339-0151-17 | Natco | 10 cups | — | — | FDA listed | — |
| childrens allergy 12.5 mg/5mL 30142-0651-26 | Kroger | 1 bottle | — | — | FDA listed | — |
| CVS dye-free childrens allergy 12.5 mg/5mL 51316-0710-08 | CVS | 1 bottle | — | — | FDA listed | — |
| Allergy Childrens Allergy 12.5 mg/5mL 55910-0891-04 | Dolgencorp, | 1 bottle | — | — | FDA listed | — |
| KROGER Dye Free Childrens Allergy Relief 12.5 mg/5mL 41226-0710-08 | KROGER | 1 bottle | — | — | FDA listed | — |
| allergy childrens 12.5 mg/5mL 41250-0379-26 | Meijer | 1 bottle | — | — | FDA listed | — |
| Childrens Benadryl DYE-FREE ALLERGY 12.5 mg/5mL 50580-0535-01 | Kenvue | 1 bottle | — | — | FDA listed | — |
| M-Dryl 12.5 mg/5mL 63629-1160-01 | Bryant | 473 ml | — | — | FDA listed | — |
| M-Dryl 12.5 mg/5mL 72162-1674-02 | Bryant | 120 ml | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 49580-0292-02 | P | 118 ml | — | — | FDA listed | — |
| dg health allergy childrens 12.5 mg/5mL 55910-0379-26 | Dolgencorp, | 1 bottle | — | — | FDA listed | — |
| ADWE dye-free childrens allergy 12.5 mg/5mL 68163-0710-08 | RARITAN | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 76281-0505-24 | AptaPharma | 118 ml | — | — | FDA listed | — |
| Diphenhydramine Hydrochloride 12.5 mg/5mL 83720-0502-04 | Oncor | 118 ml | — | — | FDA listed | — |
| Diphenhydramine Hydrochloride 12.5 mg/5mL 00121-0489-00 | PAI | 10 cups | — | AA | FDA listed | — |
| Diphenhydramine HCl 12.5 mg/5mL 00121-0865-00 | PAI | 10 cups | — | — | FDA listed | — |
| Wal Dryl Childrens Allergy 12.5 mg/5mL 00363-0092-08 | Walgreens | 1 bottle | — | — | FDA listed | — |
| Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 68788-7994-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 21130-0025-04 | Safeway, | 118 ml | — | — | FDA listed | — |
| Allergy Childrens 12.5 mg/5mL 37808-0012-08 | H | 1 bottle | — | — | FDA listed | — |
| Childrens Dye Free Allergy 12.5 mg/5mL 49580-0293-04 | P | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 82673-0109-04 | KinderFarms, | 1 bottle | — | — | FDA listed | — |
| QUALITY CHOICE Childrens Allergy Relief DYE FREE 12.5 mg/5mL 83324-0339-04 | QUALITY | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 53943-0505-26 | Discount | 237 ml | — | — | FDA listed | — |
| Target Dye Free Childrens Allergy Relief 12.5 mg/5mL 82442-0710-08 | Target | 1 bottle | — | — | FDA listed | — |
| Dye Free Allergy childrens 12.5 mg/5mL 63868-0128-04 | QUALITY | 1 bottle | — | — | FDA listed | — |
| childrens Allergy Dye Free Wal Dryl 12.5 mg/5mL 00363-0710-08 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Diphenhydramine HCl 12.5 mg/5mL 00904-7560-70 | Major | 10 cups | — | — | FDA listed | — |
| equate allergy relief 12.5 mg/5mL 49035-0379-26 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Dye Free Childrens Allergy Relief 12.5 mg/5mL 49035-0600-04 | WAL-MART | 1 bottle | — | — | FDA listed | — |
| Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 71205-0259-04 | Proficient | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief Dye Free Bubble Gum 12.5 mg/5mL 81522-0293-04 | FSA | 1 bottle | — | — | Discontinued | — |
| M-Dryl 12.5 mg/5mL 83939-0008-01 | VERITYRX, | 5 ml | — | — | FDA listed | — |
| Bactimicina Childrens Allergy 12.5 mg/5mL 24286-1565-04 | DLC | 1 bottle | — | — | FDA listed | — |
| Childrens Benadryl ALLERGY 12.5 mg/5mL 50580-0534-04 | Kenvue | 1 bottle | — | — | FDA listed | — |
| M-Dryl 12.5 mg/5mL 63629-1159-01 | Bryant | 120 ml | — | — | FDA listed | — |
| Dye Free Wal Dryl Allergy childrens 12.5 mg/5mL 00363-0293-04 | Walgreens | 1 bottle | — | — | FDA listed | — |
| childrens allergy relief 12.5 mg/5mL 00363-1236-26 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Topcare childrens allergy 12.5 mg/5mL 36800-0379-26 | Topco | 1 bottle | — | — | FDA listed | — |
| BENADRYL Allergy 12.5 mg/5mL 50580-0573-04 | Kenvue | 1 bottle | — | — | FDA listed | — |
| Diphenhydramine HCl 12.5 mg/5mL 60687-0829-86 | American | 10 cups | — | — | FDA listed | — |
| Winco Foods Childrens Allergy Relief Dye Free 12.5 mg/5mL 67091-0354-18 | WINCO | 1 bottle | — | — | FDA listed | — |
| Diphenhydramine hydrochloride 12.5 mg/5mLthis 31722-0600-31 | Camber | 10 cups | — | AA | FDA listed | — |
| Diphenhydramine HCL 12.5 mg/5mL 71741-0511-04 | Redmont | 118 ml | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 31722-0600-11 | 1 BOTTLE in 1 CARTON (31722-600-11) / 118 mL in 1 BOTTLE | 2026-06-17 | Active |
| 31722-0600-31 You're viewing this | 10 CARTON in 1 BOX (31722-600-31) / 10 CUP, UNIT-DOSE in 1 CARTON / 5 mL in 1 CUP, UNIT-DOSE | 2026-06-17 | Active |
Pack size FAQ
What quantity is in NDC 31722-0600-31?
What NDC number is used to bill for this package of Diphenhydramine hydrochloride 12.5 mg/5mL Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness.
Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents. Nighttime Sleep-aid.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours.
Adults 25 to 50 mg three to four times daily. The nightime sleep aid dosage is 50 mg at bedtime. Pediatric Patients, other than premature infants and neonates 12.5 mg to 25 mg three or four times daily.
Maximum daily dosage not to exceed 300 mg. For physicians who wish to calculate the dose on the basis of body weight or surface area, the recommended dosage is 5 mg/kg/24 hours or 150 mg/m 2 /24 hours. Data are not available on the use of diphenhydramine hydrochloride as a nighttime sleep-aid in children under 12 years.
The basis for determining the most effective dosage regimen will be the response of the patient to medication and the condition under treatment. In motion sickness, full dosage is recommended for prophylactic use, the first dose to be given 30 minutes before exposure to motion and similar doses before meals and upon retiring for the duration of exposure
⛔ Contraindications ▾
CONTRAINDICATIONS Use in Neonates or Premature Infants This drug should not be used in neonates or premature infants. Use in Nursing Mothers Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Antihistamines are also contraindicated in the following conditions Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.
⚠️ Warnings ▾
WARNINGS Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction. Use in Pediatric Patients In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients.
In the young pediatric patient, particularly, they may produce excitation. Use in the Elderly (approximately 60 years or older) Antihistamines are most likely to cause dizziness, sedation, and hypotension in elderly patients.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequent adverse reactions are underscored. 1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose and throat.
2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles. 3.
Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. 4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.
5. GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. 6.
GU System: Urinary frequency, difficult urination, urinary retention, early menses. 7. Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness.
To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
🤰 Pregnancy ▾
Pregnancy Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well- controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Diphenhydramine hydrochloride should not be used in neonates and premature infants (see CONTRAINDICATIONS ). Diphenhydramine hydrochloride may diminish mental alertness, or, in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death (see WARNINGS and OVERDOSAGE ). See also DOSAGE AND ADMINISTRATION section.
🆘 Overdosage ▾
OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur.
If vomiting has not occurred spontaneously, the patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precaution against aspiration must be taken, especially in infants and children.
If vomiting is unsuccessful, gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic or 1/2 isotonic saline is the lavage solution of choice. Saline cathartics, as milk of magnesia, by osmosis draw water into the bowel and therefore are valuable for their action in rapid dilution of bowel content.
Stimulants should not be used. Vasopressors may be used to treat hypotension.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour.
The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours. Diphenhydramine is widely distributed throughout the body, including the CNS. Little, if any, is excreted unchanged in the urine; most appears as the degradation products of metabolic transformation in the liver, which are almost completely excreted within 24 hours.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP- Clear, purple to red solution with cinnamon flavour, contains 12.5 mg diphenhydramine hydrochloride with 14% alcohol and is supplied as: NDC 31722-600-11 118 mL (4 oz) bottle NDC 31722-600-31 Box of 100 (10 cartons containing 10 x 5 mL unit dose cups in each.) NDC 31722-601-31 Box of 100 (10 cartons containing 10 x 10 mL unit dose cups in each.) STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing and light.
Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. By: Annora Pharma Pvt.
Ltd. Sangareddy - 502313, Telangana, India. Revised: 05/2026 camberlogo
📋 Description ▾
DESCRIPTION Diphenhydramine hydrochloride USP is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride and has the molecular formula C 17 H 21 NO•HCl (molecular weight 291.82). It occurs as a white, odorless, crystalline powder. Slowly darkens on exposure to light and is freely soluble in water, alcohol and in chloroform.
Sparingly soluble in acetone. Very slightly soluble in benzene and in ether. The structural formula is as follows: Each 5 mL contains 12.5 mg of diphenhydramine hydrochloride USP and alcohol 14% for oral administration.
Inactive Ingredients: cassia cinnamon flavour (contains cassia bark oil, cinnamic aldehyde, cinnamon leaf oil, eugenol and glyceryl triacetate), citric acid monohydrate, D&C red No. 33, ethyl alcohol dehydrated, FD&C red No. 40, purified water, sucrose and trisodium citrate dihydrate. diphenhydraminehclstruct
💬 Information for Patients ▾
Information for Patients Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.