Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL FREDS, 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
PART343
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Active ingredient Purpose (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide croscarmellose sodium FD&C blue #2 FD&C red #40 FD&C Yellow #6 gelatin hydroxypropyl cellulose hypromellose isopropyl alcohol microcrystalline cellulose n-butyl alcohol povidone pregelatinized starch propylene glycol shellac glaze stearic acid titanium dioxide triacetin.
Strengths
500 mg 25 mg
Quantities
24 count
Treats Conditions
Uses Temporary Relief Of Occasional Headaches And Minor Aches And Pains With Accompanying Sleeplessness
Pill Appearance
Shape: capsule Color: gray Imprint: G3

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0084579131624
UNII
362O9ITL9D TC2D6JAD40
Packaging

EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each Aspirin Free Non-Habit Forming 24 GELCAPS 24 Count

Package Descriptions
  • EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each Aspirin Free Non-Habit Forming 24 GELCAPS 24 Count

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 gelcaps at bedtime ■ do not take more than 2 gelcaps of this product in 24 hours children under 12 years do not use

Warnings & Precautions
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 reaction. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away.
Purpose

Purposes 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 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 ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers

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. 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 the reach of children.

Questions

Questions or comments? call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST


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