Label: TYLENOL PM- acetaminophen and diphenhydramine hydrochloride tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 52904-945-04, 52904-945-05, 52904-945-20, 52904-945-25, view more52904-945-50 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 50580-608
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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 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
- 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 - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Carton
-
INGREDIENTS AND APPEARANCE
TYLENOL PM
acetaminophen and diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-945(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 aluminum lake (UNII: J9EQA3S2JM) 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) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) stearic acid (UNII: 4ELV7Z65AP) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light 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:52904-945-04 1 in 1 BLISTER PACK 03/01/1997 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-945-05 2 in 1 BLISTER PACK 03/01/1997 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:52904-945-20 20 in 1 CARTON 03/01/1997 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:52904-945-25 25 in 1 CARTON 03/01/1997 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:52904-945-50 50 in 1 CARTON 03/01/1997 5 2 in 1 POUCH; 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 03/01/1997 Labeler - Select Corporation (053805599)
