ACETAMINOPHEN PM ACETAMINOPHEN DIPHENHYDRAMINE HCL ULAI HEALTH 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
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
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
Strengths
500 mg 25 mg
Treats Conditions
Uses Temporary Relief Of Occasional Headaches And Minor Aches And Pains With Accompanying Sleeplessness
Pill Appearance
Shape: capsule Color: blue Imprint: PH019

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0373057352034
UNII
362O9ITL9D TC2D6JAD40
Packaging

PHARBEST NDC 73057-352-03 Manufactured in the USA Extra Strength *COMPARE TO the active ingredients in TYLENOL ® PM ACETAMINOPHEN PM Pain Reliever Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl Non-habit forming 24 Caplets Ulai Pharbetol PM Caplet 24 ct. Label

Package Descriptions
  • PHARBEST NDC 73057-352-03 Manufactured in the USA Extra Strength *COMPARE TO the active ingredients in TYLENOL ® PM ACETAMINOPHEN PM Pain Reliever Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl Non-habit forming 24 Caplets Ulai Pharbetol PM Caplet 24 ct. Label

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 caplets at bedtime do not take more than 2 caplets 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 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).
Purpose

Purpose Pain reliever 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 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

When Using

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operating 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Storage & Handling

Other information store at 20-25 0 C (68-77 0 F)

Questions

Questions or comments? (866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)


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