![EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [CARDINAL HEALTH]](https://medic.hrt.org//dailymed/images/d09db275-8e25-434e-80d1-e1c8c2ef4389/extra-strength-pain-reliever-pm-1.jpg)
| NDC | 37205-759-71, 37205-759-78 |
| Set ID | d09db275-8e25-434e-80d1-e1c8c2ef4389 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CARDINAL HEALTH |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
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
Do not use
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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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in 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
Ask a doctor before use if you have
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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
Ask a doctor or pharmacist before use if you are
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taking the blood thinning drug warfarin
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taking sedatives or tranquilizers
When using this product
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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
Stop use and ask a doctor if
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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.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 37205-759-71
Compare to Extra Strength Tylenol® PM active ingredients*
LEADER®
EXTRA STRENGTH
Pain Reliever PM
Acetaminophen 500 mg, Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid
Non-habit forming50 CAPLETS
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
50844 ORG051223515DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4760310
www.myleader.com
1-800-200-6313All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Leader 44-235
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER PM
acetaminophen and diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-759 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color BLUE Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-759-71 1 in 1 CARTON 05/15/1994 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:37205-759-78 1 in 1 CARTON 05/15/1994 11/07/2019 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/15/1994 Labeler - CARDINAL HEALTH (097537435) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(37205-759) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(37205-759) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(37205-759) , PACK(37205-759) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(37205-759)