Active Ingredient(S)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Relief Pm Tablet
FDA Label NDC 69168-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Pain Relief Pm (NDC 69168-003). 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)
temporarily 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 4000 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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).
- 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
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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 A Doctor If
- sleeplessness persists continuously for more than 2 weeks.
- 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.
- You may report side effects to 1-888-952-0050
Insomnia may be a symptom of serious underlying medical illness.
These could be signs of a serious condition.
Pregnancy/Breastfeeding
If pregnant or breastfeeding, 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. 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 warning0
- adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours
- children under 12 years: do not use
Other Information
- store between 20-25 °C (68-77° F)
- do not use if imprinted safety seal under cap is broken or missing
- retain carton for full product information
Inactive Ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene
glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
Principal Display Panel
Pain Relief (Greenfield Pain Relief Pm 1)
Pain Relief (Greenfield Pain Relief Pm 2)
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