acetaminophen/diphenhydramine/phenylephrine (Benadryl Allergy and Cold, Sudafed PE Severe Cold, Delsym Cough + Cold Night Time, Children's Delsym Cough + Cold Night Time, Benadryl Severe Allergy and Sinus Headache, Children's Tylenol Plus Cold and Allergy, Benadryl Allergy and Sinus Headache, Robitussin Peak Cold Nighttime Multi-Symptom Cold, Theraflu Nighttime Severe Cold and Cough, Theraflu Warming Relief Flu and Sore Throat, Theraflu Warming Relief Nighttime Severe Cold and Cough, Tylenol Allergy Multi-Symptom Nighttime)

Dosing and uses of Benadryl Allergy and Cold, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

acetaminophen/diphenhydramine/phenylephrine

caplet

• 325mg/25mg/5mg
• 325mg/12.5mg/5mg
• 650mg/25mg/10mg

liquid

• (160mg/6.25mg/2.5mg)/5mL
• (160mg/12.5mg/2.5mg)/5mL

syrup

• 325mg/12.5mg/5mg

packet

• 650mg/25mg/10mg

 

Rhinorrhea, Nasal Congestion, Headache

Benadryl Allergy & Cold: 2 caplet PO q4hr; not to exceed 12 capsules/day

Benadryl Allergy & Sinus Headache: 2 caplet PO q4hr; not to exceed 12 capsules/day

Benadryl Severe Allergy & Sinus Headache: 2 caplet PO q4hr; not to exceed 12 capsules/day

Robitussin Peak Cold Nighttime Multi-Symptom Cold: 20 mL PO q4hr; not to exceed 6 doses/24 hr

Sudafed PE Nighttime Cold: 2 caplet PO q4hr; not to exceed 12 caplet/day

Sudafed PE Severe Cold: 2 caplet PO q4hr; not to exceed 12 caplet/day

Theraflu Nighttime Severe Cold & Cough; 1 packet dissolved in 8 oz of water PO q4hr; not to exceed 6 packet/day

Theraflu Warming Relief Nighttime Severe Cold & Cough: 2 tablespoonfuls (30 mL) PO q4hr; not to exceed 6 doses/day

Tylenol Allergy Multi-Symptom Nighttime: 2 caplet PO q4hr; not to exceed 12 caplet/day

 

Pediatric dosage forms and strengths

acetaminophen/diphenhydramine/phenylephrine

caplet

• 325mg/25mg/5mg
• 325mg/12.5mg/5mg
• 650mg/25mg/10mg

liquid

• (160mg/6.25mg/2.5mg)/5mL
• (160mg/12.5mg/2.5mg)/5mL

syrup

• 325mg/12.5mg/5mg

packet

• 650mg/25mg/10mg

 

Rhinorrhea, Nasal Congestion, Headache

Benadryl Allergy & Cold

• <6 years old: Ask a pediatrician
• 6-12 years: 1 caplet PO q4hr; not to exceed 5 capsules/day
• >12 years: 2 caplet PO q4hr; not to exceed 12 capsules/day

Benadryl Allergy & Sinus Headache

• < 6 years: Ask a pediatrician
• 6-12 years: 1 capsule PO q4hr; maximum 5 capsules/day
• >12 years: 2 capsules PO q4hr; not to exceed 12 capsules/day

Benadryl Severe Allergy & Sinus Headache

• < 6 years old: Ask a pediatrician
• 6-12 years old: 1 capsule PO q4hr; maximum 5 capsules/day
• >12 years old: 2 capsules PO q4hr; not to exceed 12 capsules/day

Children's Tylenol Plus Cold & Allergy

• <4 years old: Do not use
• 4-6 years old: Ask a pediatrician
• 6-12 years old: 10 mL PO q4hr; not to exceed 5 doses/day

Robitussin Peak Cold Nighttime Multi-Symptom Cold

• <12 years: Do not use
• 12 years or older: 20 mL PO q4hr; not to exceed 6 doses/24 hr

Sudafed PE Nighttime Cold

• <12 years old: Ask a pediatrician
• >12 years old: 2 caplets PO q4hr; not to exceed 12 caplets/day

Sudafed PE Severe Cold

• <6 years: Ask a pediatrician
• 6-12 years: 1 caplets PO q4hr; not to exceed 5 caplets/day
• >12 years: 2 caplets PO q4hr; not to exceed 12 caplets/day

Theraflu Nighttime Severe Cold & Cough

• <12 years: Ask a pediatrician
• >12 years: 1 packet dissolved in 8 oz of water PO q4hr; not to exceed 6 packet/day

Theraflu Warming Relief Flu & Sore Throat

• <12 years: Ask a pediatrician
• >12 years: 2 tablespoonfuls (30 mL) PO q4hr; not to exceed 6 doses/day

Theraflu Warming Relief Nighttime Severe Cold & Cough

• <12 years: Ask a pediatrician
• >12 years: 2 tablespoonfuls (30 mL) PO q4hr; not to exceed 6 doses/day

Tylenol Allergy Multi-Symptom Nighttime

• <12 years: Do not use
• >12 years: 2 caplets PO q4hr; not to exceed 12 caplets/day

 

Benadryl Allergy and Cold, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine) adverse (side) effects

Frequency not defined

Hypertension

Hypotension

Reflex tachycardia

Severe peripheral and visceral vasoconstriction

Tachycardia

Dizziness

Excitability

Headache

Restlessness

Sedation

Sleepiness

Tremor

Dermatologic rash

Increased appetite

Xerostomia

Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Bilirubin and alkaline phosphatase may increase

Urinary retention

 

Warnings

Contraindications

Hypersensitivity

Use within 14 days of MAO inhibitor therapy

G-6-PD deficiency

Asthma

Narrow-angle glaucoma

Symptomatic prostate hypertrophy

Bladder-neck obstruction

Severe hepatic impairment

 

Cautions

Elderly patients

Hyperthyroidism

Cardiovascular disease (bradycardia, partial heart block or severe arteriosclerosis when administering phenylephrine)

Acetaminophen hepatotoxicity possible in chronic alcoholics following various dose levels

Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

Severe or recurrent pain or high or continued fever may indicate a serious illness

Acetaminophen contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

Diphenhydramine may cause significant confusional symptoms

Diphenhydramine not for administration to premature or full-term neonates

 

Pregnancy and lactation

Pregnancy category: C

Lactation: excreted in breast milk, use caution

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Benadryl Allergy and Cold, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine)

Mechanism of action

Acetaminophen: Blocks pain impulse generation peripherally & may inhibit the prostaglandin generation in CNS; reduces fever by inhibiting hypothalamic heat-regulating center

Phenylephrine: Vasoconstrictor & decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion & tissue hyperemia

Diphenhydramine: Competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity & penetrates CNS, which causes pronounced tendency to induce sedation