Acetaminophen and Diphenhydramine hydrochloride
- Dosage form
- TABLET
- Labeler
- KROGER COMPANY
- Label updated
- 2024-09-10
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · 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 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
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
[Image in the official label — see DailyMed source]
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
[Image in the official label — see DailyMed source]
DailyMed Set ID: b9b86755-63ad-e25a-e053-2995a90ad747 · Version 5
NDC: 30142-193