Acetaminophen, Diphenhydramine Hydrochloride ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE LEADER/ CARDINAL HEALTH 110, INC. FDA Approved Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
croscarmellose sodium D&C yellow #10 aluminum lake FD&C blue #1 aluminum lake hypromellose magnesium stearate mineral oil polyvinylpyrrolidone pregelatinized starch silica sodium starch glycolate stearic acid talc titanium dioxide triacetin
Strengths
500 mg 25 mg
Treats Conditions
Uses Temporary Relief Of Occasional Headaches And Minor Aches And Pains With Accompanying Sleeplessness
Pill Appearance
Shape: oval Color: blue Imprint: CPC752

Identifiers & Packaging

Container Type UNKNOWN
UPC
0096295135299
UNII
362O9ITL9D TC2D6JAD40
Packaging

LEADER TM NDC 7000-0411-3 Extra Strength Acetaminophen PM Acetaminophen, 500mg Diphenhydramine HCl, 25mg Pain Reliever/Nighttime Sleep-Aid Non-Habit Forming COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients* 100 Caplets Cardinal Label

Package Descriptions
  • LEADER TM NDC 7000-0411-3 Extra Strength Acetaminophen PM Acetaminophen, 500mg Diphenhydramine HCl, 25mg Pain Reliever/Nighttime Sleep-Aid Non-Habit Forming COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients* 100 Caplets Cardinal 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 trouble urinating due to an enlarged 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 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.
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? (800) 231-4670


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