Other
Drug Facts
Product manufactured for:
Eagle Distributors,Inc.
Los Angeles, CA 90011
Pm Get Relief
FDA Label NDC 68737-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eagle Distributors,inc. for the product Pm Get Relief (NDC 68737-224). 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 other, otc - purpose, uses, liver warning, 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
Otc - Purpose
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep aid |
Uses
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
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 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
| Adults and children 12 years of age and over | Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. |
| Children under 12 years of age | Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems |
Other Information
- store between20-25 C (68-77 F)
- do not use if pouch is torn or open
Inactive Ingredients
croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.
Questions Or Comments?
Call 1-800-570-8650 (M-F 9am to 5pm PST)
Principal Display Panel - 50 Pouch Carton
See New Warnings Information & Directions
Compare to the Active Ingredients in
Tylenol PM®*
Extra Strength
PM
Get Relief
Pain Reliever
Nighttime Sleep Air
Acetaminophen, Diphenhydramine HCI
Principal Display Panel (50 Pouch Carton)
* Please review the disclaimer below.
