Label: ACETAMINOPHEN PM- acetaminophen, diphenhydramine hcl tablet, coated
- NDC Code(s): 63981-056-54
- Packager: COSTCO WHOLESALE CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 25, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each gelcap)
- 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- Directions
- Other information
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Inactive ingredients
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
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Principal display panel
KIRKLAND
SignatureCOMPARE TO EXTRA
STRENGTH TYLENOL® PM
active ingredients*NDC 63981-056-54
ITM. / ART. 596759EXTRA STRENGTH
ACETAMINOPHEN PM
GELCAPSAcetaminophen 500 mg
Diphenhydramine HCl 25 mgPain Reliever • Nighttime Sleep Aid
Non-Habit Forming
Temporarily Relieves:
• Headache
• Minor Aches and
Pains Accompanied
by SleeplessnessActual
Size375
GelcapsTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark
Extra Strength Tylenol® PM. 50844 REV0324N55654Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
Distributed by: Costco Wholesale Corporation
999 Lake Drive, Issaquah, WA 98027 USA
www.costco.com 22V13037aKirkland 44-556
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN PM
acetaminophen, diphenhydramine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-056 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 AMMONIA (UNII: 5138Q19F1X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (dark blue) , blue (light blue) Score no score Shape OVAL Size 20mm Flavor Imprint Code L;6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-056-54 375 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/04/2022 Labeler - COSTCO WHOLESALE CORPORATION (103391843) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(63981-056) , pack(63981-056) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(63981-056) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(63981-056) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(63981-056) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(63981-056)