![PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]](https://medic.hrt.org//dailymed/images/2a42ec97-5cb3-43e9-9ff7-a352f5e01c09/sound-body-44-235-1.jpg)
| NDC | 50844-539-12 |
| Set ID | 2a42ec97-5cb3-43e9-9ff7-a352f5e01c09 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L.N.K. International, Inc. |
| 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
- 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 product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- liver disease
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- avoid alcoholic beverages
- drowsiness will occur
- 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.
- redness or swelling is present
- new symptoms occur
- 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.
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
SOUNDBODY™
*Compare to the active ingredients in Extra Strength Tylenol® PM
NDC 50844-539-12
EXTRA STRENGTH
Pain Relief PMAcetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid100 CAPLETS
Non-habit forming
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® PM.
50844 ORG041723512
Manufactured for Big Lots Stores, Inc.
by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge NY, 11788 USA
V#733000 ITEM#022723512
Sound Body 44-235
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INGREDIENTS AND APPEARANCE
PAIN RELIEF PM
acetaminophen, diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-539 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) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:50844-539-12 1 in 1 CARTON 03/01/2019 1 100 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 03/01/2019 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(50844-539) , PACK(50844-539) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(50844-539) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(50844-539) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(50844-539)