FDA Label for Acetaminophen Pm

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (IN EACH CAPLET)
PURPOSE
USES
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Pm Product Label

The following document was submitted to the FDA by the labeler of this product Ulai Health Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

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.

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 a 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

When Using This Product

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

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).

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

Other Information

store at 20-25⁰C (68-77⁰F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, purified water, stearic acid, titanium dioxide

Questions Or Comments?

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

Package Label.Principal Display Panel

PHARBEST

NDC 73057-352-03

Manufactured in the USA

Extra Strength

*COMPARE TO the active ingredients in TYLENOL^® PM

ACETAMINOPHEN

Pain Reliever

Nighttime Sleep Aid

Acetaminophen,

Diphenhydramine HCl

Non-habit forming

24 Caplets

* Please review the disclaimer below.

Table of Contents