Kroger 44-074

Kroger 44-074
SPL v3
SPL
SPL Set ID 286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0
Route
ORAL
Published
Effective Date 2025-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (1000 mg) Diphenhydramine (50 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-22

Description

Acetaminophen 1,000 mg Diphenhydramine HCl 50 mg

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Acetaminophen 1,000 mg Diphenhydramine HCl 50 mg

Use

for the temporary relief of occasional minor aches and pains with accompanying sleeplessness

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.

Directions
  • do not take more than directed
  • mL = milliliter
  • only use the dose cup provided
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: 30 mL at bedtime
  • 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

  • in children under 12 years of age

  • if you have ever had an allergic reaction to this product or any of its ingredients

Other Information
  • each 30 mL contains: sodium 12 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • use by expiration date on package

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol,

sucralose, xanthan gum

Questions Or Comments?

Call 1-800-632-6900

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
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel Kroger

NDC 30142-093-02

Kroger® Health

COMPARE TO THE ACTIVE

INGREDIENTS INVICKS®

ZZZQUIL® NIGHT PAIN LIQUID*

MAXIMUM STRENGTH

NightTime

Pain Reliever +

Sleep Aid

Acetaminophen

Diphenhydramine HCl

PAIN RELIEVER/

NIGHTTIME

SLEEP-AID

NON-HABIT FORMING



12 YEARS

AGES

and OVER

F-074 ORG

MIDNIGHT-BERRY

FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter &

Gamble Company. VICKS® and ZzzQuil® are registered trademarks of

The Procter & Gamble Company. 50844 ORG052307402

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

For More Product Information, Scan UPC Using Your

Kroger App or Call 800-632-6900

‡OUR PHARMACIST

RECOMMENDED

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

kroger 44-074

Active Ingredients (in Each 30 Ml)

Acetaminophen 1,000 mg

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma

  • a breathing problem such as emphysema or chronic bronchitis

  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers


Structured Label Content

Use

for the temporary relief of occasional 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

  • 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.

Directions
  • do not take more than directed
  • mL = milliliter
  • only use the dose cup provided
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: 30 mL at bedtime
  • 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

  • in children under 12 years of age

  • if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)
  • each 30 mL contains: sodium 12 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • use by expiration date on package

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol,

sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-800-632-6900

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)
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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, (If pregnant or breast-feeding,)

ask a health professional before use.

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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel Kroger (Principal Display Panel - Kroger)

NDC 30142-093-02

Kroger® Health

COMPARE TO THE ACTIVE

INGREDIENTS INVICKS®

ZZZQUIL® NIGHT PAIN LIQUID*

MAXIMUM STRENGTH

NightTime

Pain Reliever +

Sleep Aid

Acetaminophen

Diphenhydramine HCl

PAIN RELIEVER/

NIGHTTIME

SLEEP-AID

NON-HABIT FORMING



12 YEARS

AGES

and OVER

F-074 ORG

MIDNIGHT-BERRY

FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter &

Gamble Company. VICKS® and ZzzQuil® are registered trademarks of

The Procter & Gamble Company. 50844 ORG052307402

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

For More Product Information, Scan UPC Using Your

Kroger App or Call 800-632-6900

‡OUR PHARMACIST

RECOMMENDED

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

kroger 44-074

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 1,000 mg

Diphenhydramine HCl 50 mg

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

  • a breathing problem such as emphysema or chronic bronchitis

  • difficulty in urination due to enlargement of the prostate gland

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


Advanced Ingredient Data


Raw Label Data

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