acetaminophen and diphenhydramine hydrochloride
acetaminophen and diphenhydramine hydrochloride is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including Tylenol PM Extra Strength, Chloraseptic Nighttime Sore Throat Hot Relief, Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime. Available dosage forms: tablet, film coated, tablet, coated, powder, for solution, solution.
Drug Details
- Generic Name
- acetaminophen and diphenhydramine hydrochloride
- Brand Names
- Tylenol PM Extra Strength, Chloraseptic Nighttime Sore Throat Hot Relief, Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
- Application Number
- M013
- Sponsor
- Select Consumer Group
- NDC Codes
- 9
- Dosage Forms
- TABLET, FILM COATED, TABLET, COATED, POWDER, FOR SOLUTION, SOLUTION
- Routes
- ORAL
- Active Ingredients
- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Indications and Usage
Use s Temporarily relieves symptoms of the common cold: • minor aches and pains • minor sore throat pain • headache • runny nose • sneezing • itchy throat or nose • itchy, watery eyes due to hay fever
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 5 doses in 24 hours, which is the maximum daily amount • 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 • in a child under 12 years of age • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other product containing diphenhydramine, even one used on the skin A sk a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis A sk a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children 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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.