Acetaminophen PM Extra Strength ACETAMINOPHEN DIPHENHYDRAMINE HCL FOODHOLD U.S.A., LLC 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
Active ingredients (in each gelcap) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients ammonium hydroxide colloidal silicon dioxide croscarmellose sodium FD&C blue #1 FD&C red #3 gelatin hydroxypropyl cellulose hypromellose iron oxide black iron oxide red iron oxide yellow microcrystalline cellulose polyethylene glycol povidone pregelatinized starch propylene glycol shellac glaze simethicone 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: oval Color: blue Imprint: L;6

Identifiers & Packaging

Container Type UNKNOWN
UPC
0341520319624
UNII
362O9ITL9D TC2D6JAD40
Packaging

Principal display panel CARE one ® NDC 41520-956-31 Compare to the active ingredients in Extra Strength Tylenol ® PM* Extra Strength ACETAMINOPHEN PM Acetaminophen, 500 mg Diphenhydramine HCl, 25 mg Pain Reliever Nighttime Sleep Aid Non-habit Forming 80 GELCAPS Actual Size OUR PHARMACISTS R x RECOMMEND TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Extra Strength Tylenol ® PM . 50844 REV0324B55631 DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back. Care One 44-556 Care One 44-556

Package Descriptions
  • Principal display panel CARE one ® NDC 41520-956-31 Compare to the active ingredients in Extra Strength Tylenol ® PM* Extra Strength ACETAMINOPHEN PM Acetaminophen, 500 mg Diphenhydramine HCl, 25 mg Pain Reliever Nighttime Sleep Aid Non-habit Forming 80 GELCAPS Actual Size OUR PHARMACISTS R x RECOMMEND TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Extra Strength Tylenol ® PM . 50844 REV0324B55631 DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back. Care One 44-556 Care One 44-556

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 adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps 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 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. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis liver disease difficulty 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 drowsiness will occur avoid alcoholic beverages 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 a serious underlying medical illness. any new symptoms appear redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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. Prompt 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.

When Using

When using this product drowsiness will occur avoid alcoholic beverages 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 a serious underlying medical illness. any new symptoms appear redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number

Questions

Questions or comments? 1-800-426-9391


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