Members Mark 44-556

Label at a glance#

Label contents#

Full prescribing information#

Active ingredients (in each gelcap)

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

• 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• liver disease
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland

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 beverages
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• any new symptoms appear
• fever gets worse or lasts more than 3 days
• redness or swelling is present

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

STORAGE AND HANDLING SECTION

• use by expiration date on package
• avoid high humidity
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO EXTRA STRENGTH
TYLENOL® PM
ACTIVE INGREDIENTS*

Member's
Mark_™

NDC 68196-556-54

EXTRA STRENGTH

Acetaminophen PM
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg

Pain Reliever/Nighttime Sleep-Aid

•NON-HABIT FORMING
•RELIEVES HEADACHE AND
MINOR ACHES & PAINS
ACCOMPANIED BY
SLEEPLESSNESS

375 GELCAPS
ACTUAL SIZE

Related RxNorm Concepts#

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

• acetaminophen pm extra strength
• acetaminophen, diphenhydramine HCl
• ACETAMINOPHEN
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• AMMONIA
• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• FD&C BLUE NO. 1
• FD&C RED NO. 3
• GELATIN, UNSPECIFIED
• HYDROXYPROPYL CELLULOSE, UNSPECIFIED
• HYPROMELLOSE, UNSPECIFIED
• FERROSOFERRIC OXIDE
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE, UNSPECIFIED
• STARCH, CORN
• PROPYLENE GLYCOL
• SHELLAC
• STEARIC ACID
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

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.