Diphenhydramine Hydrochloride and Acetaminophen

FDA Drug Profile — RiteAid Nighttime Sleep Aid, Vicks ZzzQuil Night Pain, CVS Nighttime Sleep Aid

Drug Details

Generic Name
Diphenhydramine Hydrochloride and Acetaminophen
Brand Names
RiteAid Nighttime Sleep Aid, Vicks ZzzQuil Night Pain, CVS Nighttime Sleep Aid
Application Number
M010
Sponsor
RITE AID CORPORATION
NDC Codes
4
Dosage Forms
LIQUID, TABLET, COATED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

Uses ▪ for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if ▪ adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product ▪ taken 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 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. ▪ for children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate machinery 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 • new symptoms occur • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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 at 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.