ACETAMINOPHEN, DIPHENHYDRAMINE: 10 Adverse Event Reports & Safety Profile
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Active Ingredient: ACETAMINOPHEN, DIPHENHYDRAMINE CITRATE · Route: ORAL · Manufacturer: The Procter & Gamble Manufacturing Company · HUMAN OTC DRUG · FDA Label: Available
What Are the Most Common ACETAMINOPHEN, DIPHENHYDRAMINE Side Effects?
All ACETAMINOPHEN, DIPHENHYDRAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Completed suicide | 8 | 80.0% | 8 | 0 |
Who Reports ACETAMINOPHEN, DIPHENHYDRAMINE Side Effects? Age & Gender Data
Average age: 36.7 years. Most reports from: US. View detailed demographics →
Official FDA Label for ACETAMINOPHEN, DIPHENHYDRAMINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Uses for the temporary relief of minor aches and pains associated with: sore throat headache muscular aches backache
Dosage & Administration
Directions take only as directed do not exceed 3 doses (30 mL each) per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL every 6 hours children under 12 yrs ask a doctor
Directions take only one dose (30 mL) per day (24 hours) only use the dose cup provided only use as directed adults & children 12 yrs & over 30 mL at bedtime children under 12 yrs do not use
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Active Ingredient
Active ingredients (in each 30 mL)
Acetaminophen
1000 mg Diphenhydramine HCl 50 mg Purpose Pain reliever Nighttime sleep-aid
Active ingredients (in each 30 mL)
Acetaminophen
1000 mg Purpose Pain reliever
Inactive Ingredients
Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, polysorbate 20, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum