Extra Strength Pain Reliever PM
Medically reviewed on February 13, 2018
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CARDINAL HEALTH
NDC Code: 37205-759
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.
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain reliever
Nighttime sleep-aid
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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more than 4,000 mg of acetaminophen in 24 hours
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with other drugs containing acetaminophen
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3 or more alcoholic drinks every day while using this product
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with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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with any other product containing diphenhydramine, even one used on skin
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for children under 12 years of age
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if you are allergic to acetaminophen or any of the inactive ingredients in this product
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liver disease
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a breathing problem such as emphysema or chronic bronchitis
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trouble urinating due to an enlarged prostate gland
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glaucoma
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taking the blood thinning drug warfarin
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taking sedatives or tranquilizers
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drowsiness will occur
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avoid alcoholic beverages
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do not drive a motor vehicle or operate machinery
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sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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new symptoms occur
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redness or swelling is present
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pain gets worse or lasts more than 10 days
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fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
ask a health professional before use.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
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store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
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see end flap for expiration date and lot number
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide
1-800-426-9391
NDC 37205-759-71
Compare to Extra Strength Tylenol® PM active ingredient*
LEADER®
EXTRA STRENGTH
Pain Reliever PM
Acetaminophen 500 mg, Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid
Non-habit forming
50 CAPLETS
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
50844 ORG051223515
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OH 43017
CIN 4760310
www.myleader.com
1-800-200-6313
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Leader 44-235
| EXTRA STRENGTH PAIN RELIEVER PM
acetaminophen and diphenhydramine hcl tablet, film coated |
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| Labeler - CARDINAL HEALTH (097537435) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 038154464 | PACK(37205-759) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 967626305 | PACK(37205-759) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 832867837 | MANUFACTURE(37205-759), PACK(37205-759) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 868734088 | PACK(37205-759) | |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
