Drug Facts
Composition & Profile
Identifiers & Packaging
NDC 0904-6731-51 MAJOR Extra Strength Acetaminophen PM Caplets Acetaminophen and Diphenhydramine HCl 500mg/25mg Pain Reliever/ Nighttime Sleep Aid Compare to active ingredient oin Extra Strength TYLENOL PM* 50 Caplets Major Label
- NDC 0904-6731-51 MAJOR Extra Strength Acetaminophen PM Caplets Acetaminophen and Diphenhydramine HCl 500mg/25mg Pain Reliever/ Nighttime Sleep Aid Compare to active ingredient oin Extra Strength TYLENOL PM* 50 Caplets Major Label
Overview
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Indications & Usage
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Dosage & Administration
Directions ■ do not take more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. ■ children under 12 years: do not use
Warnings & Precautions
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4,000 mg of acetaminophen in 24 hours ■ 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 product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ■ liver disease ■ a breathing problem such as emphysema or chronic bronchitis ■ difculty in urination due to enlargement of the prostate gland ■ glaucoma 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 ■ do not drive a motor vehicle or operate machinery ■ drowsiness will occur Stop use and ask a doctor if ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose
Purpose Pain reliever Nighttime sleep-aid
Do Not Use
Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you have ever had an allergic reaction to this product or any of its ingredients
When Using
When using this product ■ avoid alcoholic beverages ■ do not drive a motor vehicle or operate machinery ■ drowsiness will occur
Stop Use & Ask a Doctor
Stop use and ask a doctor if ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children.
Questions
Questions or comments? Call (800) 231-4670
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