FDA Label for Acetaminophen And Diphenhydramine Hydrochloride

Drug Facts

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg
Diphenhydramine hydrochloride USP 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

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.

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

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

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.

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
  
  

Other Information

• avoid high humidity
• store at 20° to 25°C (68° 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?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

Code: TS/DRUGS/16/2014

Package Label-Principal Display Panel 500 Mg / 25 Mg (50 Caplets Bottle)

NDC 30142-193-14
Kroger^®

Extra Strength
Acetaminophen PM
Acetaminophen USP, 500 mg

Diphenhydramine
Hydrochloride USP, 25 mg
Pain Reliever,
Nighttime Sleep Aid
Rapid-Release

Non-Habit Forming

50 GELCAPS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets - aurophen fig1

Package Label-Principal Display Panel 500 Mg / 25 Mg (50 Caplets Bottle Carton)

COMPARE TO the active ingredients of                            NDC 30142-193-14
EXTRA STRENGTH TYLENOL^® PM ^*See top panel
Kroger^®
Extra Strength

Acetaminophen PM
Acetaminophen USP, 500 mg
Diphenhydramine Hydrochloride USP, 25 mg
Pain Reliever, Nighttime Sleep Aid,
Rapid Release

Non-Habit Forming
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

actual size
50 GELCAPS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton) - aurophen fig2