NDC | 67414-608-00, 67414-608-06 |
Set ID | 639f4e01-9723-a619-e053-2991aa0a549a |
Category | HUMAN OTC DRUG LABEL |
Packager | Jones Packaging Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Drug Facts
- Active ingredients (in each caplet)
- 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?
- Tylenol 50 Pouches Tray
-
INGREDIENTS AND APPEARANCE
TYLENOL PM EXTRA STRENGTH
acetaminophen, diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67414-608 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 (15 MPA.S AT 5%) (UNII: 68401960MK) 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) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 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:67414-608-06 50 in 1 TRAY 01/25/2018 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67414-608-00 2500 in 1 BOX 01/25/2018 2 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 01/25/2018 Labeler - Jones Packaging Inc (243697187) Registrant - Jones Packaging Inc (243697187) Establishment Name Address ID/FEI Business Operations Jones Packaging Inc 243697187 pack(67414-608) Establishment Name Address ID/FEI Business Operations McNeil Healthcare LLC. 831188763 manufacture(67414-608)