Active Ingredient
Acetaminophen 500 mg
Diphenhydramine 25 mg
Pain Relief Pm Tablet
FDA Label NDC 72090-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Pain Relief Pm (NDC 72090-006). 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, purpose, uses:, warnings:, ask doctor:, ask doctor/pharmacist:, pregnancy, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Reliever/fever reducer
Nighttime sleep-aid
Uses:
temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness
Warnings:
This product contains acetaminophen. Severe liver damage can 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
- Skin reddening
- blisters
- rash
- 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 ever had an allergic reaction to this product or any of its ingredients
Allergy Alert:
Acetamenophen may cause severe skin reactions,symptoms may include
If skin reaction occour stop use and seek medical help right away
Ask Doctor:
- liver disease
- glaucoma
- a breathing problem such as emphysema, or chronic bronchitis
- trouble urinating due to enlarged prostate gland
Ask Doctor/Pharmacist:
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using this product
•drowsiness will occur
•avoid alcoholic beverages
•do not drive 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
•new symptoms occur
•redness or swelling is present
•new symptoms occurThese could be signs of a serious condition.
Pregnancy
If pregnant or breast-feeding,
ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away at 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 bedtime
- do not take more than 2 caplets in 24 hours unless directed by doctor
- children under 12 years do not use
Other Information
- store at 20°-25°C (68°-77°F)
- do not use if foil or inner seal is broken or missing
Inactive Ingredients
pregelatinized starch, povidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, talc
Questions Or Comments?
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
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