Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Diphenhydramine 25 mg
Pain Relief Pm Tablet
FDA Label NDC 84324-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Pain Relief Pm (NDC 84324-005). 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 ingredients (in each caplet), purpose, uses:, warnings:, do not use, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are, 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
Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................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 ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland.
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.
Directions:
■ do not take more than directed (see overdose warning) adults and children 12 years and over
■ take 2 caplets at bedtime
■ do not take more than 2 caplets in 24 hours unless directed by a doctor
■ children under 12 years do not use
Other Information:
- store at 20°-25°C (68°-77°F)
Inactive Ingredients:
FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.
Questions Or Comments?
Call 1-718-337-8733 or visit [email protected]
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