Acetaminophen PM Extra Strength ACETAMINOPHEN DIPHENHYDRAMINE HCL UNITED NATURAL FOODS, INC. DBA UNFI 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
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each geltab) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients corn starch croscarmellose sodium D&C red #27 aluminum lake edible black ink FD&C blue #1 aluminum lake gelatin glycerin hypromellose maltodextrin microcrystalline cellulose polyethylene glycol povidone purified water silicon dioxide stearic acid titanium dioxide
Strengths
500 mg 25 mg
Treats Conditions
Uses Temporary Relief Of Occasional Headaches And Minor Aches And Pains With Accompanying Sleeplessness
Pill Appearance
Shape: round Color: white Imprint: BP50

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0041163265394
UNII
362O9ITL9D TC2D6JAD40
Packaging

Principal Display Panel Compare to Extra Strength Tylenol® PM active ingredients* Extra Strength acetaminophen PM acetaminophen 500 mg Diphenhydramine HCl 25 mg pain reliever/nighttime sleep-aid Geltabs GLUTEN FREE *This product is not manufactured or distributed by Kenvue Brands LLC., distributor of Extra Strength Tylenol® PM. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908 USA; Product Label EQUALINE Extra Strength Pain Reliever Nighttime Sleep Aid Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Package Descriptions
  • Principal Display Panel Compare to Extra Strength Tylenol® PM active ingredients* Extra Strength acetaminophen PM acetaminophen 500 mg Diphenhydramine HCl 25 mg pain reliever/nighttime sleep-aid Geltabs GLUTEN FREE *This product is not manufactured or distributed by Kenvue Brands LLC., distributor of Extra Strength Tylenol® PM. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908 USA
  • Product Label EQUALINE Extra Strength Pain Reliever Nighttime Sleep Aid Acetaminophen 500 mg Diphenhydramine HCl 25 mg

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 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. children under 12 years: do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in24 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 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 skin in children under 12 years of age 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 drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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 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 skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients

When Using

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery

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 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. 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.

Storage & Handling

Other information store between 20-25ºC (68-77ºF) avoid high humidity and excessive heat

Questions

Questions or comments? Call toll free 1-855-423-2630


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