Pain Relief PM by Family Dollar (FAMILY WELLNESS) Drug Facts
Pain Relief PM by
Drug Labeling and Warnings
Pain Relief PM by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated
Family Dollar (FAMILY WELLNESS)
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.
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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
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 products 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 problems 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 a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
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 of this product in 24 hours.
- children under 12 years: do not use
Inactive ingredients
croscarmellose sodium*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol* povidone K30, pregelatanized starch, purified water, silicon dioxide, sodium starch glycolate, talc, titanium dioxide
Principal Display Panel
COMPARE TO EXTRA STRENGTH TYLENOL® PM ACTIVE INGREDIENTS*
Extra Strength Pain Relief PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever, Nighttime Sleep Aid
Caplets
*This product is not manufactured or distributed by McNeil Consumer Healthcare distributor of Extra Strength Tylenol® PM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY CHESAPEAKE, VA 23320
| PAIN RELIEF PM
EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated |
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| Labeler - Family Dollar (FAMILY WELLNESS) (024472631) |