Label: TYLENOL PM- acetaminophen, diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 50269-608-06
- Packager: JC World Bell Wholesale Co., Inc.
- This is a repackaged label.
- Source NDC Code(s): 50580-608
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 8, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each caplet)
- Uses
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Warnings
This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:
acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:
• skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.
- 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
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
- 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 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
- redness or swelling is present
- new symptoms occur
- These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
TYLENOL PM
acetaminophen, diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50269-608(NDC:50580-608) 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 19mm Flavor Imprint Code TY;PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50269-608-06 25 in 1 BOX; Type 0: Not a Combination Product 08/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/16/2018 Labeler - JC World Bell Wholesale Co., Inc. (805257581) Establishment Name Address ID/FEI Business Operations JC World Bell Wholesale Co., Inc. 805257581 repack(50269-608) Establishment Name Address ID/FEI Business Operations McNeil Healthcare LLC 831188763 manufacture(50269-608)
