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SPL v5

SPL

SPL Set ID b9b86755-63ad-e25a-e053-2995a90ad747

Route

ORAL

Published

Effective Date 2024-09-10

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Ammonia Ferrosoferric Oxide Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Fd&c Red No. 3 Gelatin, Unspecified Hydroxypropyl Cellulose (110000 Wamw) Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Polyethylene Glycol 4000 Povidone K90 Starch, Corn Propylene Glycol Shellac Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: T;6 Shape: capsule Color: blue Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-03-06

Description

Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg

Purpose

Pain reliever Nighttime sleep-aid

Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg

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:

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.

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

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

Drug Facts

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg

Diphenhydramine hydrochloride USP 25 mg

Other Information

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

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.

Questions Or Comments?

Call 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code: TS/DRUGS/16/2014

When Using This Product

drowsiness will occur
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have

liver disease
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

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 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

Structured Label Content

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purpose

Pain reliever

Nighttime sleep-aid

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.

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

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

Drug Facts

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg

Diphenhydramine hydrochloride USP 25 mg

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code: TS/DRUGS/16/2014

When Using This Product (When using this product)

drowsiness will occur
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Package Label Principal Display Panel 500 Mg / 25 Mg (50 Caplets Bottle) (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 500 Mg / 25 Mg (50 Caplets Bottle Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton))

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "Purpose": "Pain reliever Nighttime sleep-aid", "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.", "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", "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", "Drug Facts": "Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg", "Other information": "avoid high humidity store at 20º to 25°C (68º to 77°F) use by expiration date on package", "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.", "Questions or comments?": "Call 1-800-632-6900 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 MADE IN INDIA Code: TS/DRUGS/16/2014", "When using this product": "drowsiness will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery", "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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "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.", "Ask a doctor before use if you have": "liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers", "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 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:37.430285 · Updated: 2026-03-14T23:03:47.044278