Pain Reliever PM ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE MAGNO-HUMPHRIES, INC. 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 ingredient (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg Purpose Nighttime sleep aid
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide croscarmellose sodium FD&C blue #1 aluminum lake FD&C blue #2 aluminum lake hypromellose microcrystalline cellulose polyethylene glycol polysorbate povidone pregelatinized starch 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: G651

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0043292562405
UNII
362O9ITL9D TC2D6JAD40
Packaging

Package Labeling: Label2

Package Descriptions
  • Package Labeling: Label2

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) take 2 caplets at bedtime; do not take more than 2 caplets of this product in 24 hours adults and children 12 years and over: do not use children under 12 years:

Warnings & Precautions
Warnings This product contains acetaminophen. Severe liver damage may occur if you take Liver warning: acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert: If a skin reaction occurs, stop use and seek medical help right away. 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 skin reddening blisters rash 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 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers 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 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Overdose warning:
Purpose

Purpose 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 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 operate 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Overdose warning:

Questions

Questions? call toll-free 1-800-935-6737


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