Benadryl® Allergy Cold
Acetaminophen; Diphenhydramine; Pseudoephedrine
Brand Name(s): Benadryl® Allergy Cold, Benadryl® Allergy Sinus Headache, Benadryl® Cold NightTime Formula, Children’s Tylenol® Allergy-D, Maximum Strength Tylenol® Allergy Sinus NightTime, Maximum Strength Tylenol® Flu NightTime | Benadryl® Allergy and Cold | Benadryl® Allergy and Sinus Headache | Benadryl® Severe Allergy and Sinus Headache® | Childrens Tylenol® Allergy-D | Diphedryl® Allergy Sinus Headache | Equate® Allergy and Sinus Headache | Sudafed® Sinus Nighttime Plus Pain Relief | Tylenol® Allergy Sinus Night Time | Tylenol® Flu Night Time | Tylenol® PM Allergy Sinus | Wal-Dryl™ Allergy and Sinus Headache
Classification:
» Analgesics
Antihistamines
» H1-blockers
» Sedating H1-blockers
Autonomic Agents
» Sympathomimetics
» Adrenergic agonists
Respiratory Agents
» Adrenergic agonists
» Decongestants
Comments:
Description: Acetaminophen, diphenhydramine, and pseudoephedrine are used together in an oral preparation to relieve symptoms associated with the common cold, allergic rhinitis or other upper respiratory allergies, or flu symptoms. Specifically, they are used for the temporary relief of rhinorrhea, sneezing, itching of the nose or throat, itchy and/or watery eyes, nasal and sinus congestion, sinus pain, and sinus headache. Some products are also marketed for body aches, headaches, fever, pharyngitis, and other flu symptoms. Acetaminophen is a non-narcotic analgesic; its analgesic effect may be produced by a direct action on the pain threshold due to inhibition of prostaglandin synthesis. Its analgesic activity may also be related to inhibition of the synthesis or actions of chemical mediators or other substances that sensitize pain receptors to mechanical or chemical stimulation. Diphenhydramine is an H1-receptor antagonist that dries nasal and sinus passages secondary to its anticholinergic activity. Diphenhydramine produces CNS depression, resulting in diminished alertness, slowed reaction times, and somnolence. In some products, diphenhydramine is included for its sedative effect to facilitate sleep in patients with pain or discomfort. Pseudoephedrine is a sympathomimetic agent that stimulates alpha1-adrenergic receptors in vascular smooth muscle. This causes vasoconstriction, resulting in shrinkage of nasal mucous membranes, reduction of tissue hyperemia and edema, and an increase in nasal airway patency. Pseudoephedrine is commonly diverted for use as a substrate for the illegal synthesis of amphetamine and methamphetamine. As a result, the Combat Methamphetamine Epidemic Act of 2005 is being implemented. This Act governs the sale and purchase of all OTC products containing pseudoephedrine, ephedrine, or phenylpropanolamine in the U.S.. Retailers must keep products in locked cabinets or behind counters prior to purchase, enter individual product purchases and amounts into a log and maintain it for at least 2 years following each sale, require photo identification and verify customer-required entries into the log, and ensure daily and monthly allowable limits on purchases are not exceeded (review Patriot Act Title VII for more information on legal requirements).
Contraindications and Precautions: Acetaminophen-containing products should not be used for self-medication in patients who drink 3 or more alcoholic beverages per day. Diphenhydramine may cause drowsiness; patients should be advised not to drive or operate machinery until the effects of the drug are known. These products may cause excitability, especially in children. If nervousness, insomnia, or dizziness occurs, discontinue and consult a physician. Pseudoephedrine is contraindicated in patients with severe hypertension or in patients taking monoamine oxidase inhibitors. Pseudoephedrine-containing products are relatively contraindicated in patients with ischemic heart disease and should be used with caution in patients with hypertension, diabetes mellitus, peripheral vascular disease, glaucoma, hyperthyroidism, or prostatic hypertrophy. In addition, patients with chronic bronchitis or emphysema should not use these products.
Benadryl Allergy and Sinus Headache Caplets (Tablet 500;12.5;30 mg;mg;mg) 
Drug Interactions:
- Acetaminophen: Avoid concurrent use of products that contain acetaminophen as the maximum daily dose (i.e., 4 g/day for adults; 75 mg/kg/day for infants and children) may be exceeded leading to an increased risk of hepatotoxicity.
- Alcohol: Limit alcoholic beverages while on this product to avoid additive sedation or intoxication. Do not exceed 3 alcoholic beverages/day since products contain acetaminophen.
- MAO Inhibitors: Use of this product along with MAOIs or for 2 weeks after stopping the MAOl drug is contraindicated.
- Sedatives and hypnotics: May cause additive drowsiness.
Available as:
Benadryl® Allergy Cold (Parke-Davis), per tablet:
acetaminophen 500 mg
diphenhydramine 12.5 mg
pseudoephedrine 30 mg
Benadryl® Allergy Sinus Headache (Parke-Davis), per caplet or gelcap:
acetaminophen 500 mg
diphenhydramine 12.5 mg
pseudoephedrine 30 mg
Children’s Tylenol® Allergy-D liquid (McNeil), per 5 ml:
acetaminophen 160 mg
diphenhydramine 12.5 mg
pseudoephedrine 15 mg
Maximum Strength Tylenol® Allergy Sinus NightTime (McNeil), per caplet:
acetaminophen 500 mg
diphenhydramine 25 mg
pseudoephedrine 30 mg
Maximum Strength Tylenol® Flu NightTime (McNeil), per gelcap:
acetaminophen 500 mg
diphenhydramine 25 mg
pseudoephedrine 30 mg
Dosage:
Benadryl® Allergy Sinus Headache or Benadryl® Allergy Cold (oral dosage):
Adults and children >= 12 years: 2 tablets, caplets, or gelcaps PO every 6 hours while symptoms persist. Do not exceed 8 tablets, caplets, or gelcaps per 24 hours. Do not take for more than 10 days.
Children’s Tylenol® Allergy-D liquid (oral dosage):
Children 6 - 11 years (48 - 95 lbs): 2 teaspoonfuls PO every 4 - 6 hours, not to exceed 4 doses/day. Do not take for pain for more than 5 days or for fever for more than 3 days.
Children < 6 years: Consult a physician.
Maximum Strength Tylenol® Allergy Sinus NightTime (oral dosage):
Adults and children >= 12 years: 2 caplets PO at bedtime. Do not take for pain for more than 7 days, or for fever for more than 3 days unless directed by a physician.
Maximum Strength Tylenol® Flu NightTime (oral dosage):
Adults and children >= 12 years: 2 gelcaps PO at bedtime. May repeat every 6 hours, not to exceed 8 gelcaps in 24 hours.
Indications:
- allergic rhinitis
- common cold
- fever
- headache
- mild pain
- nasal congestion
- rhinorrhea
- sneezing
Product Photographs
Chemical Structure(s) For: Acetaminophen; Diphenhydramine; Pseudoephedrine
[ Revised 5/11/2006 3:19:00 PM ]
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