Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE KROGER COMPANY FDA Approved Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg
Inactive Ingredients
Inactive ingredients ammonium hydroxide black iron oxide colloidal silicon dioxide croscarmellose sodium FD&C blue #1 FD&C red #3 gelatin hydroxypropyl cellulose magnesium stearate microcrystalline cellulose polyethylene glycol povidone pregelatinized starch (maize) propylene glycol shellac glaze talc and 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: T;6

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
362O9ITL9D TC2D6JAD40
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle) NDC 30142-193-14 Kroger ® health NON-HABIT FORMING EXTRA STRENGTH Acetaminophen PM Acetaminophen USP, 500 mg Diphenhydramine Hydrochloride USP, 25 mg PAIN RELIEVER, NIGHTTIME SLEEP-AID RAPID RELEASE 50 GELCAPS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton) NDC 30142-193-14 Kroger ® health COMPARE TO THE ACTIVE INGREDIENTS OF EXTRA STRENGTH TYLENOL ® PM* NON-HABIT FORMING EXTRA STRENGTH Acetaminophen PM Acetaminophen USP, 500 mg Diphenhydramine Hydrochloride USP, 25 mg DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN PAIN RELIEVER, NIGHTTIME SLEEP-AID RAPID RELEASE 50 GELCAPS ACTUAL SIZE PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle) NDC 30142-193-14 Kroger ® health NON-HABIT FORMING EXTRA STRENGTH Acetaminophen PM Acetaminophen USP, 500 mg Diphenhydramine Hydrochloride USP, 25 mg PAIN RELIEVER, NIGHTTIME SLEEP-AID RAPID RELEASE 50 GELCAPS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton) NDC 30142-193-14 Kroger ® health COMPARE TO THE ACTIVE INGREDIENTS OF EXTRA STRENGTH TYLENOL ® PM* NON-HABIT FORMING EXTRA STRENGTH Acetaminophen PM Acetaminophen USP, 500 mg Diphenhydramine Hydrochloride USP, 25 mg DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN PAIN RELIEVER, NIGHTTIME SLEEP-AID RAPID RELEASE 50 GELCAPS ACTUAL SIZE PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton)

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 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
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 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.
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 pharmacist. with any other product containing diphenhydramine, even one used on skin if you are allergic to acetaminophen or any of the inactive ingredients in this product in children under 12 years of age

When Using

When using this product drowsiness will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. new symptoms occur redness or swelling is present fever gets worse or lasts more than 3 days These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information avoid high humidity store at 20º to 25°C (68º to 77°F) use by expiration date on package

Questions

Questions or comments? Call 1-800-632-6900 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 MADE IN INDIA Code: TS/DRUGS/16/2014


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