CareOne Acetaminophen PM

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

• CareOne Acetaminophen PM
• Acetaminophen, Diphenhydramine HCl
• ACETAMINOPHEN
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• 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

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.