Active Ingredient(S)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Extra Strength Pain Relief Pm
FDA Label NDC 53943-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Extra Strength Pain Relief Pm (NDC 53943-024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Nighttime sleep aid
Use(S)
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
- 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
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 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
- 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 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.
Pregnancy/Breastfeeding
Ask a health professional before use.
Keep Out Of Reach Of Children
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. 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.
Directions
- do not take more than directed (see overdose warning)
- take 2 caplets at bedtime
- do not take more than 2 caplets of this product in 24 hours
| adults and children 12 years and over | |
| children under 12 years | do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
Storage
- store between 20-25°C (68-77°F)
- do not use is carton is opened, or neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
- see end panel for lot number and expiration date
Inactive Ingredient Section
Croscarmellose sodium, FD&C blue #1, Hypromellose, Microcrsytalline cellulose, Polyethylene glycol, Stearic acid, Titanium Dioxide.
Principal Display Panel
Carton Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
50 COATED CAPLETS
50ct-ddm-ad-carton (Fig 1)
Bottle Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
50 COATED CAPLETS
50ct-ddm-ad-bot (Fig 2)
CARTON LABEL PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
100 COATED CAPLETS
100-ddm-ad-carton (Fig 3)
Bottle Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
100 COATED CAPLETS
100-ddm-ad-bottle (Fig 4)
Bottle Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
300 COATED CAPLETS
300-ddm-ad-bottle (Fig 5)
* Please review the disclaimer below.
