meijer EXTRA STRENGTH Pain Relief PM CAPLET
meijer EXTRA STRENGTH Pain Relief PM CAPLET
376fed3b-7625-6379-e063-6394a90a188d
HUMAN OTC DRUG LABEL
Aug 5, 2025
Meijer, Inc.
DUNS: 006959555
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Diphenhydramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Packaging
INDICATIONS & USAGE SECTION
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
SPL UNCLASSIFIED SECTION
COMPARE TO TYLENOL® PM EXTRA STRENGTH ACTIVE INGREDIENTS*
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
WWW.MEIJER.COM
PRODUCT OF INDIA
*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Tylenol®
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever
Nighttime sleep aid
WARNINGS SECTION
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.
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
Ask a doctor before use if you have
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged 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 drinks
• 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 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.
Overdose warning: In case of overdose, get medical help or contact a
Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
•do not take more than directed (see overdose warning)
|
adults and children 12 years and over |
• take 2 caplets at bedtime |
|
children under 12 years |
do not use |
STORAGE AND HANDLING SECTION
Other information
• store at controlled room temperature 20–25°C (68–77°F)
• protect from light, heat and moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol 400, polyvinyl pyrrolidone,
pregelatinized starch, stearic acid powder, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-888-577-8033 Monday - Friday 8am - 4pm EST