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 & Cold, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine)
- Benadryl Allergy & Cold, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine) adverse (side) effects
- Warnings
- Pregnancy
- Pharmacology of Benadryl Allergy & Cold, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine)
Dosing and uses of Benadryl Allergy and Cold, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine)
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