PAIN RELIEVER PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated
L&R DISTRIBUTORS, INC.
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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SEL - 1095 - 2019-1016
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 2 caplets in 24 hours, which is the maximum daily amount for this product
- 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 other product 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
- 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
These could be signs of a serious condition.
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
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
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| children under 12 years |
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Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide
PRINCIPAL DISPLAY PANEL
SEE NEW WARNINGS INFORMATION
select brand®
the lower price name brand
NDC 15127-033-01
EXTRA STRENGTH / NON-ASPIRIN
PAIN RELIEVER PM
SAFETY SEALED
NON-ASPIRIN PAIN RELIEVER • NIGHTTIME SLEEP AID
†Compare to the Active Ingredients of Extra Strength Tylenol® PM
Diphenhydramine HCl 25 mg
Acetaminophen 500 mg
100 CAPLETS
| PAIN RELIEVER PM
EXTRA STRENGTH
acetaminophen and diphenhydramine hydrochloride tablet, coated |
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| Labeler - L&R DISTRIBUTORS, INC. (012578514) |