Pain Relief PM by TOP CARE (Topco Associates LLC) DRUG FACTS
Pain Relief PM by
Drug Labeling and Warnings
Pain Relief PM by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated
TOP CARE (Topco Associates LLC)
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
DRUG FACTS
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 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 other products containing diphenhydramine, even one used on skin
- in children under 12 years of age
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.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition
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.
Inactive ingredients
corn starch*, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose*, maltodextrin*, microcrystalline cellulose*, polyethylene glycol*, povidone*, purified water, silicon dioxide*, stearic acid, titanium dioxide
*contains one or more of these ingredients
Principal Display Panel
Compare to extra strength TYLENOL® PM active ingredients**
Pain Relief PM
Extra Strength
ACETAMINOPHEN, 500 mg
DIPHENHYDRAMINE HCl, 25 mg
- pain reliever
- nighttime sleep-aid
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
| PAIN RELIEF PM
EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
| Labeler - TOP CARE (Topco Associates LLC) (006935977) |