ACETAMINOPHEN PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE RETAIL BUSINESS SERVICES , 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) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep-aid
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide croscarmellose sodium D&C red #28 D&C yellow #10 edible ink FD&C blue #1 FD&C blue #2 aluminum lake FD&C red #40 FD&C red #40 aluminum lake FD&C yellow #6 aluminum lake gelatin hydroxypropyl cellulose hypromellose microcrystalline cellulose povidone pregelatinized starch stearic acid 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: gray Imprint: G3

Identifiers & Packaging

Container Type UNKNOWN
UPC
0341520319624
UNII
362O9ITL9D TC2D6JAD40
Packaging

PRINCIPAL DISPLAY PANEL CAREone® NDC 72476-171-03 Compare to the actrive ingredients in Tylenol® PM Extra Strength† Extra Strength ACETAMINOPHEN PM Acetaminophen - Pain Reliever Diphenhydramine HCl - Nighttime Sleep Aid For Adults Actual Size 80 GELCAPS image description

Package Descriptions
  • PRINCIPAL DISPLAY PANEL CAREone® NDC 72476-171-03 Compare to the actrive ingredients in Tylenol® PM Extra Strength† Extra Strength ACETAMINOPHEN PM Acetaminophen - Pain Reliever Diphenhydramine HCl - Nighttime Sleep Aid For Adults Actual Size 80 GELCAPS image description

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 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 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. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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

Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg 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. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information store between 20-25ºC (68-77ºF) retain carton for complete product information


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