American Sales Company Acetaminophen Pm Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Carnauba Wax Crospovidone, Unspecified Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Povidone, Unspecified Sodium Starch Glycolate Type A Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L437;PM Shape: oval Color: blue Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-09-02 Until 2019-04-12

Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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.

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

Do Not Use

•
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.
•
with any other product containing diphenhydramine, even one used on skin
•
if you have ever had an allergic reaction to this product or any of its ingredients

Inactive Ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel

CAREone^®

Compare to the active ingredients in Tylenol^®PM

Extra Strength

ACETAMINOPHEN PM

Acetaminophen, 500mg

Diphenhydramine HCl, 25mg

Actual Size

Pain Reliever/Nighttime Sleep-Aid

For Adults

Non-habit forming

Gluten Free

50 CAPLETS

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

•
new symptoms occur
•
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

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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

•
liver disease
•
glaucoma
•
trouble urinating due to an enlarged prostate gland
•
a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

•
taking the blood thinning drug warfarin
•
taking sedatives or tranquilizers

Structured Label Content

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purpose

Pain reliever

Nighttime sleep-aid

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.

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

Do Not Use (Do not use)

•
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.
•
with any other product containing diphenhydramine, even one used on skin
•
if you have ever had an allergic reaction to this product or any of its ingredients

Inactive Ingredients (Inactive ingredients)

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel

CAREone^®

Compare to the active ingredients in Tylenol^®PM

Extra Strength

ACETAMINOPHEN PM

Acetaminophen, 500mg

Diphenhydramine HCl, 25mg

Actual Size

Pain Reliever/Nighttime Sleep-Aid

For Adults

Non-habit forming

Gluten Free

50 CAPLETS

When Using This Product (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 (Stop use and ask a doctor if)

•
new symptoms occur
•
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

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
liver disease
•
glaucoma
•
trouble urinating due to an enlarged prostate gland
•
a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

•
taking the blood thinning drug warfarin
•
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "Purpose": "Pain reliever Nighttime sleep-aid", "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.", "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", "Do not use": "• 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. • with any other product containing diphenhydramine, even one used on skin • if you have ever had an allergic reaction to this product or any of its ingredients", "Inactive ingredients": "carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide", "Principal Display Panel": "CAREone ® Compare to the active ingredients in Tylenol ® PM Extra Strength ACETAMINOPHEN PM Acetaminophen, 500mg Diphenhydramine HCl, 25mg Actual Size Pain Reliever/Nighttime Sleep-Aid For Adults Non-habit forming Gluten Free 50 CAPLETS", "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": "• new symptoms occur • 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 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.", "Active ingredients (in each caplet)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "• liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis", "Ask a doctor or pharmacist before use if you are": "• taking the blood thinning drug warfarin • taking sedatives or tranquilizers"}

American Sales Company Acetaminophen Pm Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information