pain relief PM
HTE-1095-2025-0520
0afb6181-d0b1-4845-8230-faabf1b997dc
HUMAN OTC DRUG LABEL
May 20, 2025
HARRIS TEETER
DUNS: 047279351
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen and Diphenhydramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Harris Teeter™
Extra Strength
NDC 72036-095-02
Acetaminophen PM
†Compare to the Active Ingredients in Tylenol® PM Extra Strength Caplets
Acetaminophen & Diphenhydramine
PAIN RELIEVER / NIGHTTIME SLEEP AID
For Adults
50 CAPLETS
Actual Size
INDICATIONS & USAGE SECTION
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-844-705-4384
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
|
Active ingredients |
Purpose |
|---|---|
|
Acetaminophen 500 mg |
Pain reliever |
|
Diphenhydramine HCl 25 mg |
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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
do not take more than directed (see**overdose warning***)**
|
adults and children 12 years and over |
|
|
children under 12 years |
|
STORAGE AND HANDLING SECTION
Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information